§ 360j. General provisions respecting control of devices intended for human use

Footnotes

1. 1 See Delayed Applicability of Amendment note below.
2. 2 So in original. Probably should be “The term ‘device’,”.
3. 3 So in original. Probably should be “sections”.

Legislative history

Reconstructed from this section’s Code source credit and amendment notes, resolved against the local Statutes at Large. Editorial notes are evidence, not the law that made the change.

1. 1938

   Medical Device Amendments of 1976

   Pub. L. 94–295 § 2 · 90 Stat. 539

   Enacted · 21 U.S.C. § 360j

   June 25, 1938, ch. 675, § 520, as added Pub. L. 94–295, § 2, May 28, 1976, 90 Stat. 565

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 520, as added Pub. L. 94–295, § 2, May 28, 1976, 90 Stat. 565

   Enacted provision · exact public law section
   Sec. 2. regulation of medical devices Chapter V is amended by adding after section 512 the following new sections: “classification of devices intended for human use “Sec. 513. “Device Classes (a) (1) There are established the following classes of devices intended for human use: “(A) Class I, General Controls.— “(i) A device for which the controls authorized by or under 21 USC 351, 352, 360. Post, pp. 560, 562, 564, 565. section 501, 502, 510, 516, 518, 519, or 520 or any combination of such sections are sufficient to provide reasonable assurance of the safety and effectiveness of the device. “(ii) A device for which insufficient information exists to determine that the controls referred to in clause (i) are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish a performance standard to provide such assurance, but because it— “(I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and “(II) docs not present a potential unreasonable risk of illness or injury, is to be regulated by the controls referred to in clause (i). “(B) Class II, Performance Standards.— A device which cannot be classified as a class I device because the controls authorized by or under sections 501, 502, 510, 516, 518, 519, and 520 by themselves are insufficient to provide reasonable assurance 21 USC 351, 352, 360. Post, pp. 560, 562, 564, 565. of the safety and effectiveness of the device, for which there is sufficient information to establish a performance standard to provide such assurance, and for which it is therefore necessary to establish for the device a performance standard under section 514 to provide reasonable assurance of its safety and Post, p. 546. effectiveness. “(C) Class III, Premarket Approval.— A device which because— “(i) it (I) cannot be classified as a class I device because insufficient information exists to determine that the controls authorized by or under sections 501, 502, 510, 516, 518, 519, and 520 are sufficient to provide reasonable assurance of the safety and effectiveness of the device and (II) cannot be classified as a class II device because insufficient information exists for the establishment of a, performance standard to provide reasonable assurance of its safety and effectiveness, and “(ii) (I) is purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, or “(II) presents a potential unreasonable risk of illness or injury, is to be subject, in accordance with section 515, to premarket Post, p. 552. approval to provide reasonable assurance of its safety and effectiveness. If there is not sufficient information to establish a performance standard for a device to provide reasonable assurance of its safety and effectiveness, the Secretary may conduct such activities as may be necessary to develop or obtain such information. “(2) For purposes of this section and sections 514 and 515, the safety and effectiveness of a device are to be determined— “(A) with respect to the persons for whose use the device is represented or intended, “(B) with respect to the conditions of use prescribed, recommended, or suggested in the labeling of the device, and “(C) weighing any probable benefit to health from the use of the device against any probable risk of injury or illness from such use. “(3) (A) Except as authorized by subparagraph (B), the effectiveness of a device is, for purposes of this section and sections 514 and 515, to be determined, in accordance with regulations promulgated by the Secretary, on the basis of well-controlled investigations, including clinical investigations where appropriate, by experts qualified by training and experience to evaluate the effectiveness of the device, from which investigations it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device. “(B) If the Secretary determines that there exists valid scientific evidence (other than evidence derived from investigations described in subparagraph (A))— “(i) which is sufficient to determine the effectiveness of a device, and “(ii) from which it can fairly and responsibly be concluded by qualified experts that the device will have the effect it purports or is represented to have under the conditions of use prescribed, recommended, or suggested in the labeling of the device, Post, pp. 546, 552. then, for purposes of this section and sections 514 and 515, the Secretary may authorize the effectiveness of the device to be determined on the basis of such evidence. “Classification; Classification Panels “(b) (1) For purposes of— “(A) determining which devices intended for human use should be subject to the requirements of general controls, performance standards, or premarket approval, and “(B) providing notice to the manufacturers and importers of such devices to enable them to prepare for the application of such requirements to devices manufactured or imported by them, the Secretary shall classify all such devices (other than devices classified by subsection (f)) into the classes established by subsection (a). Panels of experts. Establishment. For the purpose of securing recommendations with respect to the classification of devices, the Secretary shall establish panels of experts or use panels of experts established before the date of the enactment of this section, or both. Section 14 of the Federal Advisory 5 USC app. 1. Committee Act shall not apply to the duration of a panel established under this paragraph. “(2) The Secretary shall appoint to each panel established under paragraph (1) persons who are qualified by training and experience to evaluate the safety and effectiveness of the devices to be referred to the panel and who, to the extent feasible, possess skill in the use of, or experience in the development, manufacture, or utilization of, such devices. The Secretary shall make appointments to each panel so that each panel shall consist of members with adequately diversified expertise in such fields as clinical and administrative medicine, engineering, biological and physical sciences, and other related professions. Tn addition, each panel shall include as non voting members a representative of consumer interests and a representative of interests of the device manufacturing industry. Scientific, trade, and consumer organizations shall be afforded an opportunity to nominate individuals for appointment to the panels. No individual who is in the regular full-time employ of the United States and engaged in the administration of this Act may be a member of any panel. The Secretary shall designate one of the members of each panel to serve as chairman thereof. “(3) Panel members (other than officers or employees of the United States), while attending meetings or conferences of a panel or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, but not at rates exceeding the daily equivalent of the rate in effect for grade GS–18 of the General 5 USC 5332 note. Schedule, for each day so engaged, including traveltime; and while so serving away from their homes or regular places of business each member may be allowed travel expenses (including per diem in lieu of subsistence) as authorized by section 5703(b) of title 5, United States Code, for persons in the Government service employed intermittently. “(4) The Secretary shall furnish each panel with adequate clerical and other necessary assistance. “Classification Panel Organization and Operation “(c) (1) The Secretary shall organize the panels according to the various fields of clinical medicine and fundamental sciences in which devices intended for human use are used. The Secretary shall refer a device to be classified under this section to an appropriate panel established or authorized to be used under subsection (b) for its review and for its recommendation respecting the classification of the device. The Secretary shall by regulation prescribe the procedure to be followed by the panels in making their reviews and recommendations. In making their reviews of devices, the panels, to the maximum extent practicable, shall provide an opportunity for interested persons to submit data and views on the classification of the devices. “(2) (A) Upon completion of a panel’s review of a device referred to it under paragraph (1), the panel shall, subject to subparagraphs (B) and (C), submit to the Secretary its recommendation for the classification of the device. Any such recommendation shall (i) contain (I) a summary of the reasons for the recommendation, (II) a summary of the data upon which the recommendation is based, and (III) an identification of the risks to health (if any) presented by the device with respect to which the recommendation is made, and (ii) to the extent practicable, include a recommendation for the assignment of a priority for the application of the requirements of section 514 or 515 to a device recommended to be classified in class II or Post, pp. 546, 552. class III. “(B) A recommendation of a panel for the classification of a device in class I shall include a recommendation as to whether the device should be exempted from the requirements of section 510, 519, or 520(f). 21 USC 360. Post, pp. 564, 565. “(C) In the case of a device which has been referred under paragraph (1) to a panel, and which— “(i) is intended to be implanted in the human body or is purported or represented to be for a use in supporting or sustaining human life, and “(ii) (I) has been introduced or delivered for introduction into interstate commerce for commercial distribution before the date of enactment of this section, or “(II) is within a type of device which was so introduced or delivered before such date and is substantially equivalent to another device within that type, such panel shall recommend to the Secretary that the device be classified in class III unless the panel determines that classification of the device in such class is not necessary to provide reasonable assurance of its safety and effectiveness. If a panel does not recommend that such a device be classified in class III, it shall in its recommendation I o the Secretary for the classification of the device set forth the reasons for not recommending classification of the device in such class. “(3) The panels shall submit to the Secretary within one year of the date funds are first appropriated for the implementation of this section their recommendations respecting all devices of a type introduced or delivered for introduction into interstate commerce for commercial distribution before the date of the enactment of this section. “Classification “(d) (1) Upon receipt of a recommendation from a panel respecting a device, the Secretary shall publish in the Federal Register the panel’s recommendation and a proposed regulation classifying such device and shall provide interested persons an opportunity to submit comments on such recommendation and the proposed regulation. After reviewing such comments, the Secretary shall, subject to paragraph (2), by regulation classify such device. “(2) (A) A regulation under paragraph (1) classifying a device in class I shall prescribe which, if any, of the requirements of section 21 USC 360. Post, pp. 564, 565. 510, 519, or 520(f) shall not apply to the device. A regulation which makes a requirement of section 510, 519, or 520(f) inapplicable to a device shall be accompanied by a statement of the reasons of the Secretary for making such requirement inapplicable. “(B) A device described in subsection (c) (2) (C) shall be classified in class III unless the Secretary determines that classification of the device in such class is not necessary to provide reasonable assurance of its safety and effectiveness. A proposed regulation under paragraph (1) classifying such a device in a class other than class III shall be accompanied by a full statement of the reasons of the Secretary (and supporting documentation and data) for not classifying such device in such class and an identification of the risks to health (if any) presented by such device. “(3) In the case of devices classified in class II and devices classified under this subsection in class III and described in section 515(b) (1) the Secretary may establish priorities which, in his discretion, shall Post, p. 546. be used in applying sections 514 and 515, as appropriate, to such devices. “Classification Changes “(e) Based on new information respecting a device, the Secretary may, upon his own initiative or upon petition of an interested person, by regulation (1) change such device’s classification, and (2) revoke, because of the change in classification, any regulation or requirement in Publication in Federal Register. effect under section 514 or 515 with respect to such device. In the promulgation of such a regulation respecting a device’s classification, the Secretary may secure from the panel to which the device was last referred pursuant to subsection (c) a recommendation respecting the proposed change in the device’s classification and shall publish in the Federal Register any recommendation submitted to the Secretary by the panel respecting such change. A regulation under this subsection changing the classification of a device from class III to class II may provide that such classification shall not take effect until the effective date of a performance standard established under section 514 for such device. “Initial Classification of Certain Devices “(f) (1) Any device intended for human use which was not introduced or delivered for introduction into interstate commerce for commercial distribution before the date of the enactment of this section is classified in class III unless— “(A) the device— “(i) is within a type of device (I) which was introduced or delivered for introduction into interstate commerce for commercial distribution before such date and which is to be classified pursuant to subsection (b), or (II) which was not so introduced or delivered before such date and has been classified in class I or II, and “(ii) is substantially equivalent to another device within such type, or “(B) the Secretary in response to a petition submitted under paragraph (2) has classified such device in class I or II. A device classified in class III under this paragraph shall be classified in that class until the effective date of an order of the Secretary under paragraph (2) classifying the device in class I or II. “(2) (A) The manufacturer or importer of a device classified under Petition. paragraph (1) may petition the Secretary (in such form and manner as he shall prescribe) for the issuance of an order classifying the device in class I or class II. Within thirty days of the filing of such Notification. a petition, the Secretary shall notify the petitioner of any deficiencies in the petition which prevent the Secretary from making a decision on the petition. “(B) (i) Upon determining that a petition does not contain any deficiency which prevents the Secretary from making a decision on the petition, the Secretary shall refer the petition to an appropriate panel established or authorized to be used under subsection (b). A panel to which such a petition has been referred shall not later than ninety days after the referral of the petition make a recommendation to ti e Secretary respecting approval or denial of the petition. Any such recommendation shall contain (1) a summary of the reasons for the recommendation, (II) a summary of the data upon which the recommendation is based, and (III) an identification of the risks to health (if any) presented by the device with respect to which the petition was filed. In the case of a petition for a device which is intended to be implanted in the human body or which is purported or represented to be for a use in supporting or sustaining human life, the panel shall recommend that the petition be denied unless the panel determines that the classification in class III of the device is not necessary to provide reasonable assurance of its safety and effectiveness. If the panel recommends that such petition be approved, it shall in its recommendation to the Secretary set forth its reasons for such recommendation. “(ii) The requirements of paragraphs (1) and (2) of subsection (c) (relating to opportunities for submission of data and views and recommendations respecting priorities and exemptions from sections 510, 519, and 520(f) ) shall apply with respect to consideration by 21 USC 360. Post, pp. 564, 565. panels of petitions submitted under subparagraph (A). “(C) (i) Within ninety days from the date the Secretary receives the recommendation of a panel respecting a petition (but not later than 210 days after the filing of such petition) the Secretary shall by order deny or approve the petition. If the Secretary approves the petition, the Secretary shall order the classification of the device into class I or class II in accordance, with the criteria prescribed by subsection (a) (1) (A) or (a) (1) (B). In the case of a petition for a device which is intended to be implanted in the human body or which is purported or represented to be; for a use in supporting or sustaining human life, the Secretary shall deny the petition unless the Secretary determines that, the classification in class III of the device is not necessary to provide reasonable assurance of its safety and effectiveness. An order approving such petition shall be accompanied by a full statement of the reasons of the Secretary (and supporting documentation and data) for approving the petition and an identification of the risks to health (if any) presented by the device to which such order applies. “(ii) The requirements of paragraphs (1) and (2) (A) of subsec-tion (d) (relating to publication of recommendations, opportunity for submission of comments, and exemption from sections 510, 519, 21 USC 360. Post, pp. 564, 565. and 520(f)) shall apply with respect to action by the Secretary on petitions submitted under subparagraph (A). “Information “(g) Within sixty days of the receipt of a written request of any person for information respecting the class in which a device has been classified or the requirements applicable to a device under this Act, the Secretary shall provide such person a written statement of the classification (if any) of such device and the requirements of this Act applicable to the device. “Definitions “(h) For purposes of this section and sections 501, 510, 514, 515, 516, 519, and 520— “(1) a reference to ‘general controls’ is a reference to the controls authorized by or under sections 501, 502, 010, 516, 618, 519, and 520, “(2) a reference to ‘class I’, ‘class II’, or ‘class III’ is a reference to a class of medical devices described in subparagraph (A), (B), or (C) of subsection (a) (1), and “(3) a reference to a ‘panel under section 513’ is a reference to a panel established or authorized to be used under this section. “performance standards “Sec. 514. “Provisions of Standards (a) (1) The Secretary may by regulation, promulgated in accordance with this section, establish a performance standard for a class II device. A class III device may also be considered a class II device for purposes of establishing a standard for the device under this section i f the device has been reclassified as a class II device under a regulation under section 513(e) but such regulation provides that the reclassification is not to take effect until the effective date of such a standard for the device. “(2) A performance standard established under this section for a device— “(A) shall include provisions to provide reasonable assurance of its safe and effective performance; “(B) shall, where necessary to provide reasonable assurance of its safe and effective performance, include— “(i) provisions respecting the construction, components, ingredients, and properties of the device and its compatibility with power systems and connections to such systems, “(ii) provisions for the testing (on a sample basis or, if necessary, on an individual basis) of the device or, if it is determined that no other more practicable means are available to the Secretary to assure the conformity of the device to the standard, provisions for the testing (on a sample basis or, if necessary, on an individual basis) by the Secretary or by another person at the direction of the Secretary, “(iii) provisions for the measurement of the performance characteristics of the device, “(iv) provisions requiring that the results of each or of certain of the tests of the device required to be made under clause (ii) show that the device is in conformity with the portions of the standard for which the test or tests were required, and “(v) a provision requiring that the sale and distribution of the device be restricted hut only to the extent that the sale and distribution of a device may be restricted under a regulation under section 520(e); and Post, p. 565. Labeling. “(C) shall, where appropriate, require the use and prescribe the form and content of labeling for the proper installation, maintenance, operation, and use of the device. “(4) The Secretary shall provide for periodic evaluation of performance Periodic evaluation. standards established under this section to determine if such standards should be changed to reflect new medical, scientific, or other technological data. “(5) In carrying out his duties under this section, the Secretary shall, to the maximum extent practicable— “(A) use personnel, facilities, and other technical support available in other Federal agencies, “(B) consult with other Federal agencies concerned with standard-setting and other nationally or internationally recognized standard-setting entities, and “(C) invite appropriate participation, through joint or other conferences, workshops, or other means, by informed persons representative of scientific, professional, industry, or consumer organizations who in his judgment can make a significant contribution. “Initiation of a Proceeding for a Performance Standard “(b) (1) A proceeding for the development of a performance standard Publication in Federal Register. for a device shall be initiated by the Secretary by the publication in the Federal Register of notice or the opportunity to submit to the Secretary a request (within fifteen days of the date of the publication of the notice) for a change in the classification of the device based on new information relevant to its classification. “(2) If, after publication of a notice pursuant to paragraph (1) the Secretary receives a request for a change in the device’s classification, he shall, within sixty days of the publication of such notice and after consultation with the appropriate panel under section 513, by Ante, p. 540. order published in the Federal Register, either deny the request for change in classification or give notice of his intent to initiate such a change under section 513(e). “Invitation for Standards “(c) (1) If, after the publication of a notice under subsection (b), Publication in Federal Register. no action is required under paragraph (2) of such subsection or the Secretary denies a request to change the classification of the device with respect to which such notice was published, the Secretary shall publish in the Federal Register a notice inviting any person, including any Federal agency, to— “(A) submit to the Secretary, within sixty days after the date of publication of the notice, an existing standard as a proposed performance standard for such device, or “(B) offer, within sixty days after the date of publication of the notice, to develop such a proposed standard. “(2) A notice published pursuant to paragraph (1) for an offer for the development, of a proposed performance standard for a device— “(A) shall specify a period within which the standard is to be developed, which period may be extended by the Secretary for good cause shown; and “(B) shall include— “(i) a description or other designation of the device, “(ii) a statement of the nature of the risk or risks associated with the use of the device and intended to be controlled by a performance standard, “(iii) a summary of the data on which the Secretary has found a need for initiation of the proceeding to develop a performance standard, and “(iv) identification of any existing performance standard known to the Secretary which may be relevant to the proceeding. “(3) The Secretary shall by regulation require that an offeror of an offer to develop a proposed performance standard submit (and if the offeror is a business entity, require that appropriate directors, officers, and employees of, and consultants to, the business entity submit) to the Secretary such information concerning the offeror as the Secretary determines is relevant with respect to the offeror’s qualifications to develop a proposed performance standard for a device, including information respecting the offeror’s financial stability, expertise, and experience, and any potential conflicts of interest, including financial interest in the device for which the proposed standard is to be developed, current industrial or commercial affiliates of the offeror, current sources of financial support for research and business entities in which the offeror has a financial interest, which may be relevant with respect to the offeror’s qualifications. Such information submitted by an offeror may not be made public by the Secretary unless required by section 552 of title 5, United States Code, except that in the case of information submitted by an offeror whose offer has been accepted, the Secretary shall make such information (other than information which because of subsection (b)(4) of section 552, title 5, United States Code, is exempt from disclosure pursuant to subsection (a) of such section) public at the time the offer is accepted. “(4) If the Secretary determines that a performance standard can be developed by any Federal agency (including an agency within the Department of Health. Education, and Welfare), the Secretary may— “(A) if such determination is made with respect to an agency within such Department, develop such a standard in lieu of accepting any offer to develop such a standard pursuant to a notice published pursuant to this subsection, or “(B) if such determination is made with respect to any other agency, authorize such agency to develop such a standard in lieu of accepting any such offer. In making such a determination respecting a Federal agency, the Secretary shall take into account the personnel and expertise within such agency. The requirements described in subparagraphs (B) and (C) of subsection (e) (4) shall apply to development of a standard under this paragraph. “Acceptance of Certain Existing Standards “(d) (1) If the Secretary— “(A) determines that a performance standard has been issued or adopted or is being developed by any Federal agency or by any other qualified entity or receives a performance standard submitted pursuant to a notice published pursuant to subsection (c), and “(B) determines that such performance standard is based upon scientific data and information and has been subjected to scientific consideration, he may, in lieu of accepting any offer to develop such a standard pursuant to a notice published pursuant to subsection (c), accept such standard as a proposed performance standard for such device or as a basis upon which a proposed performance standard may be developed. “(2) If a standard is submitted to the Secretary pursuant to a notice Publication in Federal Register. published pursuant to subsection (c) and the Secretary does not accept such standard, he shall publish in the Federal Register notice of that fact together with the reasons therefor. “Acceptance of Offer To Develop Standard “(e) (1) Except as provided by subsections (c)(4) and (d), the Secretary shall accept one, and may accept more than one, offer to develop a proposed performance standard for a device pursuant to a notice published pursuant to subsection (c) if he determines that (A) the offeror is qualified to develop such a standard and is technically competent to undertake and complete the development of an appropriate performance standard within the period specified in the notice, and (B) the offeror will comply with procedures prescribed by regulations of the Secretary under paragraph (4) of this subsection. In determ filing the qualifications of an offeror to develop a standard, the Secretary shall take into account the offeror’s financial stability, expertise, experience, and any potential conflicts of interests (including financial interest in the device for which such standard is to be developed) and other information submitted pursuant to subsection (c) (3), which may be relevant with respect, to the offeror’s qualifications. “(2) The Secretary shall publish in the Federal Register the name Publication in Federal Register. and address of each person whose offer is accepted under paragraph (1) and a summary of the terms of such offer as accepted. “(3) If such an offer is accepted, the Secretary may, upon application which may be made prior to the acceptance of the offer, agree to contribute to the offeror’s cost in developing a proposed standard if the Secretary determines that such contribution is likely to result in a more satisfactory standard than would be developed without such contribution. The Secretary shall by regulation prescribe the items Regulation. of cost in which he will participate, except that such items may not include the cost of construction (except minor remodeling) or the acquisition of land or buildings. Payments to an offerer under this paragraph may be made without regard to section 3648 of the Revised Statutes (31 U.S.C. 529). “(4) The Secretary shall prescribe regulations governing the development Regulations. of proposed standards by persons whose offers are accepted under paragraph (1), Such regulations shall, notwithstanding subsection (b) (A) of section 553 of title 5, United States Code, be promulgated in accordance with the requirements of that section for not ice and opportunity for participation and shall— “(A) require that performance standards proposed for promulgation Performance standards. be supported by such test data or other documents or materials as the Secretary may reasonably require to be obtained; “(B) require that notice be given to interested persons of the Notice. opportunity to participate in the development of such performance standards and require the provision of such opportunity; “(C) require the maintenance of records to disclose (i) the Record maintenance. course of the development of performance standards proposed for promulgation, (ii) the comments and other information sub-nutted by any person in connection with such development, including comments and information with respect, to the need for such performance standards, and (iii) such other matters as may be relevant to the evaluation of such performance standards; “(D) provide that the Secretary and the Comptroller General of the United States, or any of their duly authorized representatives, shall have access for the purpose of audit and examination to any books, documents, papers, and other records, relevant to the expenditure of any funds contributed by the Secretary under paragraph (3); and “(E) require the submission of such periodic reports as the Secretary may require to disclose the course of the development of performance standards proposed for promulgation. “(5) If an offer is made pursuant to a notice published pursuant to subsection (c) and the Secretary does not accept such offer, he shall publish in the Federal Register notice of that fact together with the reasons therefor. “Development of Standard by Secretary After Publication of Subsection (c) Notice “(f) If the Secretary has published a notice pursuant to subsection (c) and— “(1) no person makes an offer or submits a standard pursuant to the notice; “(2) the Secretary has not accepted an existing performance standard under subsection (d) or accepted an offer to develop a proposed performance standard pursuant to the notice; or “(3) the Secretary has accepted an offer or offers to develop a proposed performance standard, but determines thereafter that— “(A) the offeror under each such offer is unwilling or unable to continue the development of the performance standard which was the subject of the offer or offers, or “(B) the performance standard which has been developed is not satisfactory, Publication in Federal Register. and publishes notice of that determination in the Federal Register together with his reasons therefor; then the Secretary may proceed to develop a proposed performance standard. The authority provided by this subsection is in addition to the authority provided by subsection (c)(4). The requirements described in subparagraphs (B) and (C) of subsection (e) (4) shall apply t° Hie development of a standard by the Secretary under this subsection. “Establishment of a Standard “(g) (1) (A) After publication pursuant to subsection (c) of a notice respecting a performance standard for a device, the Secretary shall either— “(i) publish, in the Federal Register in a notice of proposed rulemaking, a proposed performance standard for the device (I) developed by an offeror under such notice and accepted by the Secretary, (H) developed under subsection (c)(4), (HI) accepted by the Secretary under subsection (d), or (IV) developed by him under subsection (f), or “(ii) issue a notice in the Federal Register that the proceeding is terminated together with the reasons for such termination. “(B) If the Secretary issues under subparagraph (A)(ii) a notice of termination of a proceeding to establish a performance standard for a device, he shall (unless such notice is issued because the device is a banned device under section 516) initiate a proceeding under Post, p. 560. Ante, p, 540. section 513(e) to reclassify the device subject to the proceeding terminated by such notice. “(2) A notice of proposed rulemaking for the establishment of a Notice of proposed rulemaking. performance standard for a device published under paragraph (1) (A) (i) shall set forth proposed findings with respect to the degree of the risk of illness or injury designed to be eliminated or reduced by the proposed standard and the benefit to the public from the device. “(3) (A) After the expiration of the period for comment on a notice Publication in Federal Register. of proposed rulemaking published under paragraph (1) respecting a performance standard and after consideration of such comments and any report from an advisory committee under paragraph (5), the Secretary shall (i) promulgate a regulation establishing a performance standard and publish in the Federal Register findings on the matters referred to in paragraph (2), or (ii) publish a notice terminating the Notice. proceeding for the development of the standard together with the reasons for such termination. If a notice of termination is published, the Secretary shall (unless such notice is issued because the device is a banned device under section 516) initiate a proceeding under Section 513(e) to reclassify the device subject to the proceeding terminated by such notice. “(B) A regulation establishing a performance standard shall set forth the date or dates upon which the standard shall take effect, but no such regulation may take effect before one year after the date of its publication unless (i) the Secretary determines that an earlier effective date is necessary for the protection of the public health and safety, or (ii) such standard has been established for a device which, effective upon the effective date of the standard, has been reclassified from class III to class II, Such date or dates shall be established so as to minimize, consistent with the public health and safety, economic loss to, and disruption or dislocation of, domestic and international trade. “(4) (A) The Secretary, upon his own initiative or upon petition of Regulation. an interested person may by regulation, promulgated in accordance with the requirements of paragraphs (2) and (3) (B) of this subsection amend or revoke a performance standard. “(B) The Secretary may declare a proposed amendment of a performance standard to be effective on and after its publication in the Federal Register and until the effective date of any final action taken on such amendment if he determines, after affording all interested persons an opportunity for an informal hearing, that making it so effective is in the public interest. A proposed amendment of a performance standard made so effective under the preceding sentence may not prohibit, during the period in which it is so effective, the introduction or delivery for introduction into interstate commerce of a device which conforms to such standard without the change or changes provided by such proposed amendment. “(5) (A) The Secretary— “(i) may on his own initiative refer a proposed regulation for the establishment, amendment, or revocation of a performance standard, or “(ii) shall, upon the request of an interested person unless the Secretary finds the request to be without good cause or the request is made after the expiration of the period for submission of comments on such proposed regulation refer such proposed regulation, to an advisory committee of experts, established pursuant to subpara-graph (B), for a report anti recommendation with respect to any matter involved in the proposed regulation which requires the exercise of scientific judgment. If a proposed regulation is referred under this subparagraph to an advisory committee, the Secretary shall provide the advisory committee with the data and information on which such proposed regulation is based. The advisory committee shall, within Report and recommendation. sixty days of the referral of a proposed regulation and after independent study of the data and information furnished to it by the Secretary and other data and information before it, submit to the Secretary a report and recommendation respecting such regulation, together with all underlying data and information and a statement Information, availability to public. Advisory committees. Ante, p. 540. of the reason or basis for the recommendation. A copy of such report and recommendation shall be made public by the Secretary. “(B) The Secretary shall establish advisory committees (which may not be panels under section 513) to receive referrals under subparagraph (A). The Secretary shall appoint as members of any such advisory committee, persons qualified in the subject matter to be referred to the committee and of appropriately diversified professional background, except that the Secretary may not appoint to such a committee any individual who is in the regular full-time employ of the United States and engaged in the administration of this Act, Each such committee shall include as non voting members a representative of consumer interests and a representative of interests of the device manufacturing industry. Members of an advisory committee who are not officers or employees of the United States, while attending conferences or meetings of their committee or otherwise serving at the request of the Secretary, shall be entitled to receive compensation at rates to be fixed by the Secretary, which rates may not exceed the daily equivalent of the rate in effect for grade GS–18 5 USC 5332 note. of the General Schedule, for each day (including traveltime) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 of the United States Code for persons in the Government service employed intermittently. The Secretary shall designate one of the members of each advisory committee to serve as chairman Procedures, regulation. thereof. The Secretary shall furnish each advisory committee with clerical and other assistance, and shall by regulation prescribe the procedures to be followed by each such committee in acting on referrals made under subparagraph (A). “premarket approval “Sec. 515. “General Requirement (a) A class III device— “(1) which is subject to a regulation promulgated under subsection (b); or “(2) which is a class III device because of section 513(f), Post, p. 565. is required to have, unless exempt under section 520(g), an approval under this section of an application for premarket approval. “Regulation To Require Premarket Approval “(b) (1) In the case of a class III device which— “(A) was introduced or delivered for introduction into inter-state commerce for commercial distribution before the date of enactment of this section; or “(B) is (i) of a type so introduced or delivered, and (ii) is substantially equivalent to another device within that type, the Secretary shall by regulation, promulgated in accordance with this subsection, require that such device have an approval under this section of an application for premarket approval. “(2) (A) A proceeding for tile promulgation of a regulation under Publication in Federal Register. paragraph (1) respecting a device shall be initiated by the publication in the Federal Register of a notice of proposed rulemaking. Such notice shall contain— “(i) the proposed regulation; “(ii) proposed findings with respect to the degree of risk of illness or injury designed to be eliminated or reduced by requiring the device to have an approved application for premarket approval and the benefit to the public from use of the device; “(iii) opportunity for the submission of comments on the proposed regulation and the proposed findings; and “(iv) opportunity to request a change in the classification of the device based on new information relevant to the classification of the device. “(B) If, within fifteen days after publication of a notice under subparagraph Publication in Federal Register. (A), the Secretary receives a request for a change in the classification of a device, he shall, within sixty days of the publication of such notice and after consultation with the appropriate panel under section 513, by order published in the Federal Register, either deny the Ante, p. 540. request for change in classification or give notice of his intent to initiate such a change under section 513(e), “(3) After the expiration of the period for comment on a proposed Publication in Federal Register. regulation and proposed findings published under paragraph (2) and after consideration of comments submitted on such proposed regulation and findings, the Secretary shall (A) promulgate such regulation and publish in the Federal Register findings on the matters referred to in paragraph (2) (A) (ii), or (B) publish a notice terminating the proceeding for the promulgation of the regulation together with the reasons for such termination. If a notice of termination is published, the Secretary shall (unless such notice is issued because the device is a banned device under section 516) initiate a proceeding Post, p, 560, under section 513(e) to reclassify the device subject to the proceeding terminated by such notice. “(4) The Secretary, upon his own initiative or upon petition of an interested person, may by regulation amend or revoke any regulation promulgated under this subsection. A regulation to amend or revoke a regulation under this subsection shall be promulgated in accordance with the requirements prescribed by this subsection for the promulgation of the regulation to be amended or revoked. “Application for Premarket Approval “(c) (1) Any person may file with the Secretary an application for premarket approval for a class III device. Such an application for a device shall contain— “(A) full reports of all information, published or known to or which should reasonably be known to the applicant, concerning investigations which have been made to snow whether or not such device is safe and effective; “(B) a full statement of the components, ingredients, and properties and of the principle or principles of operation, of such device; “(C) a full description of the methods used in, and the facilities and controls used for, the manufacture, processing, and, when relevant, packing and installation of, such device; “(D) an identifying reference to any performance standard Ante, p. 546. under section 514 which would be applicable to any aspect of such device if it were a class II device, and either adequate information to show that such aspect of such device fully meets such performance standard or adequate information to justify any deviation from such standard: “(E) such samples of such device and of components thereof as the Secretary may reasonably require, except that where the sub-mission of such samples is impracticable or unduly burdensome, the requirement of this subparagraph may be met by the sub-mission of complete information concerning the location of one or more such devices readily available for examination and testing; “(F) specimens of the labeling proposed to be used for such device; and “(G) such other information relevant to the subject matter of the application as the Secretary, with the concurrence of the Ante, p. 540. appropriate panel under section 513, may require. “(2) Upon receipt of an application meeting the requirements set forth in paragraph (1), the Secretary shall refer such application to the appropriate panel under section 513 for study and for submission (within such period as he may establish) of a report and recommendation respecting approval of the application, together with all underlyingdata and the reasons or basis for the recommendation. “Action on an Application for Premarket Approval “(d) (1) (A) As promptly as possible, but in no event later than one hundred and eighty days after the receipt of an application under Post, p. 565. subsection (c) (except as provided in section 520(1) (3) (D) (ii) or unless, in accordance with subparagraph (B) (i), an additional period as agreed upon by the Secretary and the applicant), the Secretary, after considering the report and recommendation submitted under paragraph (2) of such subsection, shall— “(i) issue an order approving the application if he finds that none of the grounds for denying approval specified in paragraph (2) of this subsection applies; or “(ii) deny approval of the application if he finds (and sets forth the basis for such finding as part, of or accompanying such denial) that one or more grounds for denial specified in paragraph (2) of this subsection apply. “(B) (i) The Secretary may not enter into an agreement to extend the period in which to take action with respect to an application submitted for a device, subject to a regulation promulgated under subsection (b) unless he finds that, the continued availability of the device is necessary for the public health. “(ii) An order approving an application for a device may require as a condition to such approval that the sale and distribution of the device be restricted but only to the extent that the sale and distribution of a device may be restricted under a regulation under section 520(e). “(2) The Secretary shall deny approval of an application for a device if, upon the basis of the information submitted to the Secretary as part of the application and any other information before him with respect to such device, the Secretary finds that— “(A) there is a lack of a showing of reasonable assurance that such device is safe under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; “(B) there is a lack of a showing of reasonable assurance that the device is effective under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof; “(C) the methods used in, or the facilities or controls used for, the manufacture, processing, packing, or installation of such device do not conform to the requirements of section 520(f); Post, p. 565. “(D) based on a fair evaluation of all material facts, the proposed labeling is false or misleading in any particular; or “(E) such device is not shown to conform in all respects to a performance standard in effect under section 514 compliance with Ante, p. 546. which is a condition to approval of the application and there is a lack of adequate information to justify the deviation from such standard. Any denial of an application shall, insofar as the Secretary determines Statement. to be practicable, be accompanied by a statement informing the applicant of the measures required to place such application in approvable form (which measures may include further research by the applicant in accordance with one or more protocols prescribed by the Secretary). “(3) An applicant whose application has been denied approval may, Review. by petition filed on or before the thirtieth day after the date upon which he receives notice of such denial, obtain review thereof in accordance with either paragraph (1) or (2) of subsection (g), and any interested person may obtain review, in accordance with paragraph (1) or (2) of subjection (g), of an order of the Secretary approving an application. “Withdrawal of Approval of Application “(e) (1) The Secretary shall, upon obtaining, where appropriate, Notice and hearing. Ante, p. 540. advice on scientific matters from a panel or panels under section 513, and after due notice and opportunity for informal hearing to the holder of an approved application for a device, issue an order withdrawing approval of the application if the Secretary finds— “(A) that such device is unsafe or ineffective under the conditions of use prescribed, recommended, or suggested in the labeling thereof; “(B) on the basis of new information before Id in with respect to such device, evaluated together with the evidence available to him when the application was approved, that there is a lack of a showing of reasonable assurance that the device is safe or effective under the conditions of use prescribed, recommended, or suggested in the labeling thereof; “(C) that the application contained or was accompanied by an untrue statement of a material fact; “(D) that the applicant (i) has failed to establish a system Record maintenance. for maintaining records, or has repeatedly or deliberately failed to maintain records or to make reports, required by an applicable regulation under section 519(a), (ii) has refused to permit access Post, p. 564. to, or copying or verification of, such records as required by section 704, or (iii) has not complied with the requirements of 21 USC 374. 21 USC 360. section 510; “(E) on the basis of new information before him with respect to such device, evaluated together with the evidence before him when the application was approved, that the methods used in, or the facilities and controls used for, the manufacture, processing, packing, or installation of such device do not conform with the requirements of section 520(f) and were not brought into conformity with such Post, p. 565. requirements within a reasonable time after receipt of written notice from the Secretary of nonconformity; “(F) on the basis of new information before him, evaluated together with the evidence before him when the application was approved, that the labeling of such device, based on a fair evaluation of all material facts, is false or misleading in any particular and was not corrected within a reasonable time after receipt of written notice from the Secretary of such fact; or “(G) on the basis of new information before him, evaluated together with the evidence before him when the application was approved, that such device is not shown to conform in all respects Ante, p. 546. to a performance standard which is in effect under section 514 compliance with which was a condition to approval of the application and that there is a lack of adequate information to justify the deviation from such standard. “(2) The holder of an application subject to an order issued under paragraph (1) withdrawing approval of the application may, by petition filed on or before the thirtieth day after the date upon which he receives notice of such withdrawal, obtain review thereof in accordance with either paragraph (1) or (2) of subsection (g). “Product Development Protocol “(f) (1) In the case of a class III device which is required to have an approval of an application submitted under subsection (c), such device shall be considered as having such an approval if a notice of completion of testing conducted in accordance with a product development protocol approved under paragraph (4) has been declared completed under paragraph (6). “(2) Any person may submit to the Secretary a proposed product development protocol with respect to a device. Such a protocol shall be accompanied by data supporting it. If, within thirty days of the receipt of such a protocol, the Secretary determines that it appears to be appropriate to apply the requirements of this subsection to the device with respect to which the protocol is submitted, he shall refer Ante, p. 540. the proposed protocol to the appropriate panel under section 513 for its recommendation respecting approval of the protocol. “(3) A proposed product development protocol for a device may be approved only if— “(A) the Secretary determines that it is appropriate to apply the requirements of this subsection to the device in lieu of the requirement of approval of an application submitted under subsection (c); and “(B) the Secretary determines that the proposed protocol provides— “(i) a description of the device and the change« which may be made in the device, “(ii) a description of the preclinical trials (if any) of the device and a specification of (I) the results from such trials to be required before the commencement of clinical trials of the device, and (II) any permissible variations in preclinical trials and the results therefrom, “(iii) a description of the clinical trials (if any) of the device and a specification of (I) the results from such trials to be required before the filing of a notice of completion of the requirements of the protocol, and (II) any permissible variations in such trials and the results therefrom, “(iv) a description of the methods to be used in, and the facilities and controls to be used for, the manufacture, processing, and, when relevant, packing and installation of the device, “(v) an identifying reference to any performance standard under section 514 to be applicable to any aspect of such device, Ante, p. 546. “(vi) if appropriate, specimens of the labeling proposed to be used for such device, “(vii) such other information relevant to the subject matter of the protocol as the Secretary, with the concurrence of the appropriate panel or panels under section 513, may require, Ante, p. 540. and “(viii) a requirement for submission of progress reports Progress report. and, when completed, records of the trials conducted under the protocol which records are adequate to show compliance with the protocol. “(4) The Secretary shall approve or disapprove a proposed product development protocol submitted under paragraph (2) within one hundred and twenty days of its receipt unless an additional period is agreed upon by the Secretary and the person who submitted the protocol. Approval of a protocol or denial of approval of a protocol is final agency action subject to judicial review under chapter 7 of title 5, United States Code. 5 USC 701 et seq. Notice of completion. “(5) At any time after a product development protocol for a device has been approved pursuant to paragraph (4), the person for whom the protocol was approved may submit a notice of completion— “(A) stating (i) his determination that the requirements of the protocol have been fulfilled and that, to the best of his knowledge, there is no reason bearing on safety or effectiveness why the notice of completion should not become effective, and (ii) the data and other information upon which such determination was made, and “(B) setting forth the results of the trials required by the protocol and all the information required by subsection (c) (1). “(6) (A) The Secretary may, after providing the person who has Final order to revoke protocol. an approved protocol an opportunity for an informal hearing and at any time prior to receipt of notice of completion of such protocol, issue a final order to revoke such protocol if he finds that— “(i) such person has failed substantially to comply with the requirements of the protocol, “(ii) the results of the trials obtained under the protocol differ so substantially from the results required by the protocol that further trials cannot be justified, or “(iii) the results of the trials conducted under the protocol or available new information do not demonstrate that the device tested under the protocol does not present an unreasonable risk to health and safety. “(B) After the receipt of a notice of completion of an approved protocol the Secretary shall, within the ninety-day period beginning on the date such notice is received, by order either declare the protocol completed or declare it not completed. An order declaring a protocol not completed may take effect only after the Secretary has provided the person who has the protocol opportunity for an informal nearing on the order. Such an order may be issued only if the Secretary finds— “(i) such person has failed substantially to comply with the requirements of the protocol, “(ii) the results of the trials obtained under the protocol differ substantially from the results required by the protocol, or “(iii) there is a lack of a showing of reasonable assurance of the safety and effectiveness of the device under the conditions of use prescribed, recommended, or suggested in the proposed labeling thereof. “(C) A final order issued under subparagraph (A) or (B) shall be in writing and shall contain the reasons to support the conclusions thereof. “(7) At any time after a notice of completion has become effective, the Secretary may issue an order (after due notice and opportunity for an informal hearing to the person for whom the notice is effective) revoking the approval of a device provided by a notice of completion which has become effective as provided in subparagraph (B) if he finds that any of the grounds listed in subparagraphs (A) through (G) of subsection (e) (1) of this section apply. Each reference in such subparagraphs to an application shall be considered for purposes of this paragraph as a reference to a protocol and the notice of completion of such protocol, and each reference to the time when an application was approved shall be considered for purposes of this paragraph as a reference to the time when a notice of completion took effect. “(8) A person who has an approved protocol subject to an order issued under paragraph (6) (A) revoking such protocol, a person who has an approved protocol with respect to which an order under paragraph (6)(B) was issued declaring that the protocol had not been completed, or a person subject to an order issued under paragraph (7) revoking the approval of a device may, by petition filed on or before the thirtieth day after the date upon which he receives notice of such order, obtain review thereof in accordance with either paragraph (1) or (2) of subsection (g). “Review “(g) (1) Upon petition for review of— “(A) an order under subsection (d) approving or denying approval of an application or an order under subsection (e) with-drawing approval of an application, or “(B) an order under subsection (f)(6)(A) revoking an approved protocol, under subsection (f)(6)(B) declaring that an approved protocol has not been completed, or under subsection (f) (7) revoking the approval of a device, the Secretary shall, unless he finds the petition to be without good cause or unless a petition for review of such order has been submitted under paragraph (2), hold a hearing, in accordance with section 554 of title 5 of the United States Code, on the order. The panel or panels which considered the application, protocol, or device subject to such order shall designate a member to appear and testify at any such hearing upon request of the Secretary, the petitioner, or the officer conducting the hearing, but this requirement does not preclude any other member of the panel or panels from appearing and testifying at any Order. such hearing. Upon completion of such hearing and after considering the record established in such hearing, the Secretary shall issue an order either affirming the order subject to the hearing or reversing such order and, as appropriate, approving or denying approval of the application, reinstating the application’s approval, approving the protocol, or placing in effect a notice of completion. “(2) (A) Upon petition for review of— “(i) an order under subsection (d) approving or denying approval of an application or an order under subsection (e) withdrawing approval of an application, or “(ii) an order under subsection (f)(6)(A) revoking an approved protocol, under subsection (f)(6)(B) declaring that an approved protocol has not been completed, or under subsection (f) (7) revoking the approval of a device, the Secretary shall refer the application or protocol subject to the order and the basis for the order to an advisory committee of experts established pursuant to subparagraph (B) for a report and recommendation with respect to the order. The advisory committee Report and recommendation. shall, after independent study of the data and information furnished to it by the Secretary and other data and information before it, submit to the Secretary a report and recommendation, together with all under-lying data and information and a statement of the reasons or basis for the recommendation. A copy of such report shall be promptly supplied by the Secretary to any person who petitioned for such referral to the advisory committee. “(B) The Secretary shall establish advisory committees (which may Advisory committees. Establishment. not be panels under section 513) to receive referrals under subparagraph (A). The Secretary shall appoint as members of any such advisory committee persons qualified in the subject matter to be referred to the committee and of appropriately diversified professional backgrounds, except that the Secretary may not appoint to such a committee any individual who is in the regular full-time employ of the United States and engaged in the administration of this Act. Members of an advisory committee (other than officers or employees Compensation. of the United States), while attending conferences or meetings of their committee or otherwise serving at the request of the Secretary, shall be entitled to receive compensation at rates to be fixed by the Secretary, which rates may not exceed the daily equivalent for grade GS–18 of the General Schedule for each day (including traveltime) 5 USC 5332 note. they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 of the United States Code for persons in the Government service employed intermittently. The Secretary shall Chairman. designate the chairman of an advisory committee from its members. The Secretary shall furnish each advisory committee with clerical and other assistance, and shall by regulation prescribe the procedures to be followed by each such committee in acting on referrals made under subparagraph (A). “(C) The Secretary shall make public the report and recommendation Information, availability to public. made by an advisory committee with respect to an application and shall by order, stating the reasons therefor, either affirm the order referred to the advisory committee or reverse such order and, if appropriate, approve or deny approval of the application, reinstate the application’s approval, approve the protocol, or place in effect a notice of completion, “Service, of Orders “(h) Orders of the Secretary under this section shall be served (1) in person by any officer or employee of the department designated by the Secretary, or (2) by mailing the order by registered mail or certified mail addressed to the applicant at his last known address in the records of the Secretary. “banned devices “Sec. 516. “General Rule (a) Whenever the Secretary finds, on the basis of all available data and information and after consultation with the Ante, p. 540. appropriate panel or panels under section 513, that— “(1) a device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury; and “(2) in the case of substantial deception or an unreasonable and substantial risk of illness or injury which the Secretary determined could be corrected or eliminated by labeling or change in labeling and with respect to which the Secretary provided written notice to the manufacturer specifying the deception or risk of illness or injury, the labeling or change in labeling to correct the deception or eliminate or reduce such risk, and the period within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period; he may initiate a proceeding to promulgate a regulation to make such Hearing. device a banned device. The Secretary shall afford all interested persons opportunity for an informal hearing on a regulation proposed under this subsection. “Special Effective Date “(b) The Secretary may declare a proposed regulation under subsection (a) to be effective upon its publication in the Federal Register and until the effective date of any final action taken respecting such regulation if (1) he determines, on the basis of all available data and information, that the deception or risk of illness or injury associated with the use of the device which is subject to the regulation presents an unreasonable, direct, and substan rial danger to the health of individuals, and (2) before the date of the publication of such regulation, the Secretary notifies the manufacturer of such device that such Notice and hearing. regulation is to be made so effective. If the Secretary makes a proposed regulation so effective, he shall, as expeditiously as possible, give interested persons prompt notice of his action under this subsection, provide reasonable opportunity for an informal hearing on the proposed regulation, and either affirm, modify, or revoke such proposed regulation. “judicial review “Sec. 517. “Application of Section (a) Not later than thirty days after— “(1) the promulgation of a regulation under section 513 classifying a device in class I or changing the classification of a device to class I or an order under subsection (f) (2) of such section reclassifying a device or denying a petition for reclassification of a device, “(2) the promulgation of a regulation under section 514 establishing, amending, or revoking a performance standard for a device, “(3) the issuance of an order under section 514(b) (2) or 515 Ante, p. 552. (b) (2) (B) denying a request for reclassification of a device, “(4) the promulgation of a regulation under paragraph (3) of section 515(b) requiring a device to have an approval of a pre-market application, a regulation under paragraph (4) of that section amending or revoking a regulation under paragraph (3), or an order pursuant to section 515(g)(1) or 515 (g) (2) (C), Ante, p. 552. Ante, p. 560. “(5) the promulgation of a regulation under section 516 (other than a proposed regulation made effective under subsection (b) of such section upon the regulation’s publication) making a device a banned device, “(6) the issuance of an order under section 520(f) (2), or Post, p. 565. “(7) an order under section 520(g) (4) disapproving an application for an exemption of a device for investigational use or an order under section 520(g)(5) withdrawing such an exemption for a device, any person adversely affected by such regulation or order may file a petition with the United States Court of Appeals for the District of Columbia or for the circuit wherein such person resides or has his principal place of business for judicial review of such regulation or order. A copy of the petition shall be transmitted by the clerk of the court to the Secretary or other officer designated by him for that purpose. The Secretary shall file in the court the record of the proceedings on which the Secretary based his regulation or order as provided m section 2112 of title 28, United States Code. For purposes of this section, “Record.” the term ‘record’ means all notices and other matter published in the Federal Register with respect to the regulation or order reviewed, all information submitted to the Secretary with respect to such regulation or order, proceedings of any panel or advisory committee with respect to such regulation or order, any hearing held with respect to such regulation or order, and any other information identified by the Secretary, in the administrative proceeding held with respect to such regulation or order, as being relevant to such regulation or order. “Additional Data, Views, and Arguments “(b) If the petitioner applies to the court for leave to adduce additional data, views, or arguments respecting the regulation or order being reviewed and shows to the satisfaction of the court that such additional data, views, or arguments are material and that there were reasonable grounds for the petitioner’s failure to adduce such data, views, or arguments in the proceedings before the Secretary, the court may order the Secretary to provide additional opportunity for the oral presentation of data, views, or arguments and for written sub-missions. The Secretary may modify his findings, or make new findings Modifications. by reason of the additional data, views, or arguments sc taken and shall file with the court such modified or new findings, and his recommendation, if any, for the modification or setting aside of the regulation or order being reviewed, with the return of such additional data, view’s, or arguments. “Standard for Review “(c) Upon the filing of the petition tinder subsection (a) of this section for judicial review of a regulation or order, the court shall have jurisdiction to review the regulation or order in accordance with chapter 7 of title 5, United States Code, and to grant appropriate 5 USC 701 et seq. relief, including interim relief, as provided in such chapter. A regulation described in paragraph (2) or (5) of subsection (a) and an order issued after the review provided by section 515(g) shall not be affirmed if it is found to be unsupported by substantial evidence on the record taken as a whole. “Finality of Judgments “(d) The judgment of the court affirming or setting aside, in whole or in part, any regulation or order shall be final, subject to review by the Supreme Court of the United States upon certiorari or certification, as provided in section 1254 of title 28 of the United States Code. “Other Remedies “(e) The remedies provided for in this section shall be in addition to and not in lieu of any other remedies provided by law. “Statement of Reasons “(f) To facilitate judicial review under this section or under any other provision of law of a regulation or order issued under section 513, 514, 515, 516, 518, 519, 520, or 521 each such regulation or order shall contain a statement of the reasons for its issuance and the basis, in the record of the proceedings held in connection with its issuance, for its issuance. “notification and other remedies “Sec. 518. “Notification (a) If the Secretary determines that— “(1) a device intended for human use which is introduced or delivered for introduction into interstate commerce for commercial distribution presents an unreasonable risk of substantial harm to the public health, and “(2) notification under this subsection is necessary to eliminate the unreasonable risk of such harm and no more practicable means is available under the provisions of this Act (other than this section) to eliminate such risk, the Secretary may issue such order as may be necessary to assure that adequate notification is provided in an appropriate form, by the per-sons and means best suited under the circumstances involved, to all health professionals who prescribe or use the device and to any other person (including manufacturers, importers, distributors, retailers, and device users) who should properly receive such notification in order to eliminate such risk. An order under this subsection shall require that the individuals subject to the risk with respect to which the order is to be issued be included in the persons to be notified of the risk unless the Secretary determines that notice to such individuals would present, a greater danger to the health of such individuals than no such notification. If the Secretary makes such a determination with respect to such individuals, the order shall require that the health professionals who prescribe or use the device provide for the notification of the individuals whom the health professionals treated with the device of the risk presented by the device and of any action which may be taken by or on behalf of such individuals to eliminate or reduce such risk. Before issuing an order under this subsection, the Secretary shall consult with the persons who are to give notice under the order. “Repair, Replacement, or Refund “(b) (1) (A) If, after affording opportunity for an informal hearing, the Secretary determines that— “(i) a device intended for human use which is introduced or delivered for introduction into interstate commerce for commer-cial distribution presents an unreasonable risk of substantial harm to the public health, “(ii) there are reasonable grounds to believe that the device was not properly designed and manufactured with reference to the state of the art as it existed at the tune of its design and manufacture, “(iii) there are reasonable grounds to believe that the unreasonable risk was not caused by failure of a person other than a manufacturer, importer, distributor, or retailer of the device to exercise due care in the installation, maintenance, repair, or use of the device, and “(iv) the notification authorized by subsection (a) would not by itself be sufficient to eliminate the unreasonable risk and action described in paragraph (2) of this subsection is necessary to eliminate such risk, the Secretary may order the manufacturer, importer, or any distributor of such device, or any combination of such persons, to submit to him within a reasonable time a plan for taking one or more of the actions described in paragraph (2). An order issued under the preceding sentence which is directed to more than one person shall specify which person may decide which action shall be taken under such plan and the person specified shall be the person who the Secretary determines bears the principal, ultimate financial responsibility for action taken under the plan unless the Secretary cannot determine who bears such responsibility or the Secretary determines that the protection of the public health requires that such decision be made by a person (including a device user or health professional) other than the person he determines bears such responsibility. “(B) The Secretary shall approve a plan submitted pursuant to Hearing. an order issued under subparagraph (A) unless he determines (after affording opportunity for an informal hearing) that the action or actions to be taken under the plan or the manner in which such action or actions are to be taken under the plan will not assure that the unreasonable risk with respect to which such order was issued will be eliminated. If the Secretary disapproves a plan, he shall order a revised plan to be submitted to him within a reasonable time. If the Secretary Hearing. determines (after affording opportunity for an informal hearing) that the revised plan is unsatisfactory or if no revised plan or no initial plan has been submitted to the Secretary within the prescribed time, the Secretary shall (i) prescribe a plan to be carried out by the person or persons to whom the order issued under subparagraph (A) was directed, or (ii) after affording an opportunity for an informal hearing, by order prescribe a plan to be carried out by a person who is a manufacturer, importer, distributor, or retailer of the device with respect to which the order was issued but to whom the order under subparagraph (A) was not directed. “(2) The actions which may be taken under a plan submitted under an order issued under paragraph (1) arc as follows: “(A) To repair the device so that it does not present the unreasonable risk of substantial harm with respect to which the order under paragraph (1) was issued. “(B) To replace the device with a like or equivalent device which is in conformity with all applicable requirements of this Act. “(C) To refund the purchase price of the device (less a reasonable allowance for use if such device has been in the possession of the device user for one year or more— “(i) at the time of notification ordered under subsection (a),or “(ii) at th© time the device user receives actual notice of the unreasonable risk with respect to which the order was issued under paragraph (1), whichever first occurs). “(3) No charge shall be made to any person (other than a manufacturer, importer, distributor or retailer) for availing himself of any remedy, described in paragraph (2) and provided under an order issued under paragraph (1), and the person subject to the order shall reimburse each person (other than a manufacturer, importer, distributor, or retailer) who is entitled to such a remedy for any reasonable and foreseeable expenses actually incurred by such person in availing himself of such remedy. “Reimbursement “(c) An order issued under subsection (b) with respect to a device may require any person who is a manufacturer, importer, distributor, or retailer of the device to reimburse any other person who is a manufacturer, importer, distributor, or retailer of such device for such other person’s expenses actually incurred in connection with carrying out the order if the Secretary determines such reimbursement is required for the protection of the public health. Any such requirement shall not affect, any rights or obligations under any contract to which the person receiving reimbursement or the person making such reimbursement is a party. “Effect on Other Liability “(d) Compliance with an order issued under this section shall not relieve any person from liability under Federal or State law. In awarding damages for economic loss in an action brought for the enforcement of any such liability, the value to the plaintiff in such action of any remedy provided him under such order shall be taken into account. “records and reports on devices “Sec. 519. “General Rule (a) Every person who is a manufacturer, importer, or distributor of a device intended for human use shall establish and maintain such records, make such reports, and provide such information, as the Secretary may by regulation reasonably require to assure that such device is not adulterated or misbranded and to otherwise assure its safety and effectiveness. Regulations prescribed under the preceding sentence— “(1) shall not impose requirements unduly burdensome to a device manufacturer, importer, or distributor taking into account his cost of complying with such requirements and the need for the protection of the public health and the implementation of this Act.; “(2) which prescribe the procedure for making requests for reports or information shall require that each request made under such regulations for submission of a report or information to the Secretary state the reason or purpose for such request and identify to the fullest extent practicable such report or information; “(3) which require submission of a report or information to the Secretary shall state the reason or purpose for the submission of such report or information and identify to the fullest extent practicable such report or information; “(4) may not require that the identity of any patient be dis-closed in records, reports, or information required under this subsection unless required for the medical welfare of an individual, to determine the safety or effectiveness of a device, or to verify a record, report, or information submitted under this Act; and “(5) may not require a manufacturer, importer, or distributor of a class I device to— “(A) maintain for such a device records respecting information not in the possession of the manufacturer, importer, or distributor, or “(B) to submit for such a device to the Secretary any report or information— “(i) not in the possession of the manufacturer, importer, or distributor, or “(ii) on a periodic basis, unless such report or information is necessary to determine if the device should be reclassified or if the device is adulterated or misbranded. In prescribing such regulations, the Secretary shall have due regard for the professional ethics of the medical profession and the interests of patients. The prohibitions of paragraph (4) of this subsection continue to apply to records, reports, and information concerning any individual who has been a patient, irrespective of whether or when he ceases to be a patient. “Persons Exempt “(b) Subsection (a) shall not apply to— “(1) any practitioner who is licensed by law to prescribe or administer devices intended for use in humans and who manufactures or imports devices solely for use in the course of his professional practice : “(2) any person who manufactures or imports devices intended for use in humans solely for such person’s use in research or teaching and not for sale (including any person who uses a device under an exemption granted under section 520(g)); and Infra. “(3) any other class of persons as the Secretary may by regulation exempt from subsection (a) upon a finding that compliance with the requirements of such sunsection by such class with respect to a device is not necessary to ( A ) assure that a device is not adulterated or misbranded or (B) otherwise to assure its safety and effectiveness. “general provisions respecting control of devices intended for human use “Sec. 520. “General Rule (a) Any requirement authorized by or under section 501, 21 USC 360j. 21 USC 351, 352, 360. 502, 510, or 519 applicable to a device intended for human use shall apply to such device until the applicability of the requirement to the device has been changed by action taken under section 513, 514, or 515 Ante. p. 564. Ante, pu. 540, 546, 552. or under subsection (g) of this section, and any requirement established by or under section 501, 502, 510, or 519 which is inconsistent with a requirement imposed on such device under section 514 or 515 or under subsection (g) of this section shall not apply to such device. “Custom Devices “(b) Sections 514 and 515 do not apply to any device which, in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing) necessarily deviates from an otherwise applicable performance standard or requirement prescribed by or under section 515 if (1) the device is not generally available in finished form for purchase or for dispensing upon prescription and is not offered through labeling or advertising by the manufacturer, importer, or distributor thereof for commercial distribution, and (2) such device— “(A) (i) is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated) and is to be made in a specific form for such patient, or “(ii) is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated), and “(B) is not generally available to or generally used by other physicians or dentists (or other specially qualified persons so designated). “Trade Secrets “(c) Any information reported to or otherwise obtained by the Secretary or his representative under section 513, 514, 515. 516, 518, 519, Ante, pp. 540, 546, 552, 560, 562, 564. 21 USC 374. or 704 or under subsection (f) or (g) of this section which is exempt from disclosure pursuant to subsection (a) of section 552 of title 5, United States Code, by reason of subsection (b) (4) of such section shall be considered confidential and shall not be disclosed and may not be used by the Secretary as the basis for the reclassification of a device under section 513 from class III to class II or as the basis for the establishment or amendment of a performance standard under section 514 for a device reclassified from class III to class II, except that such information may be disclosed to other officers or employees concerned with carrying out this Act or when relevant in any proceeding under this Act (other than section 513 or 514 thereof). “Notices and Findings “(d) Each notice of proposed rulemaking under section 513,514,515, 516, 518, or 519, or under this section, any other notice which is published in the Federal Register with respect to any other action taken under any such section and which states the reasons for such action, and each publication of findings required to be made in connection with rulemaking under any such section shall set forth— “(1) the manner in which interested persons may examine data and other information on which the notice or findings is based, and “(2) the period within which interested persons may present their comments on the notice or findings (including the need therefor) orally or in writing, which period shall be at least sixty days but may not exceed ninety days unless the time is extended by the Secretary by a notice published in the Federal Register stating good cause therefor. “Restricted Devices “(e) (1) The Secretary may by regulation require that a device be Regulation. restricted to sale, distribution, or use— “(A) only upon the written or oral authorization of a practitioner licensed by law to administer or use such device, or “(B) upon such other conditions as the Secretary may prescribe in such regulation, if, because of its potentiality for harmful effect or the collateral measures necessary to its use, the Secretary determines that there cannot otherwise be reasonable assurance of its safety and effectiveness. No condition prescribed under subparagraph (B) may restrict the use of a device to persons with specific training or experience in its use or to persons for use in certain facilities unless the Secretary determines that such a restriction is required for the safe and effective use of the device. No such condition may exclude a person from using a device solely because the person does not have the training or experience to make him eligible for certification by a certifying board recognized by the American Board of Medical Specialties or has not been certified by such a Board. A device subject to a regulation under this subsection is a restricted device. “(2) The label of a restricted device shall bear such appropriate Labeling. statements of the restrictions required by a regulation under paragraph (1) as the Secretary may in such regulation prescribe. “Good Manufacturing Practice Requirements “(f) (1) (A) The Secretary may, in accordance with subparagraph Regulations. (B), prescribe regulations requiring that the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of a device conform to current good manufacturing practice, as prescribed in such regulations, to assure that the device will be safe and effective and otherwise in compliance with this Act. “(B) Before the Secretary may promulgate any regulation under subparagraph (A) he shall— “(i) afford the advisory committee established under paragraph Recommendations. (3) an opportunity to submit recommendations to him with respect to the regulation proposed to be promulgated, and “(ii) afford opportunity for an oral hearing. Hearing. The Secretary shall provide the advisory committee a reasonable time to make its recommendation with respect to proposed regulations under subparagraph (A). “(2) (A) Any person subject to any requirement prescribed by regulations Petition for exemption or variance. under paragraph (1) may petition the Secretary for an exemption or variance from such requirement. Such a petition shall be submitted to the Secretary in such form and manner as he shall prescribe and shall— “(i) in the case of a petition for an exemption from a requirement, set forth the basis for the petitioner’s determination that compliance with the requirement is not required to assure that the device will be safe and effective and otherwise in compliance with this Act, “(ii) in the case of a petition for a variance from a requirement, set forth the methods proposed to be used in, and the facilities and controls proposed to lie used for, the manufacture, packing, storage, and installation of the device in lieu of the methods, facilities, and controls prescribed by the requirement, and “(iii) contain such other information as the Secretary shall prescribe. “(B) The Secretary may refer to the advisory committee established under paragraph (3) any petition submitted under subparagraph Recommendations. (A). The advisory committee shall report its recommendations to the Secretary with respect to a petition referred to it within sixty days of the date of the petition’s referral. Within sixty days after— “(i) the date the petition was submitted to the Secretary under subparagraph (A), or “(ii) if the petition was referred to an advisory committee, the expiration of the sixty-day period beginning on the date the petition was referred to the advisory committee, ever occurs later, the Secretary shall by order either deny the petition or approve it. “(C) The Secretary may approve— “(i) a petition for an exemption for a device from a requirement if he determines that compliance with such requirement is not required to assure that the device will be safe and effective and otherwise in compliance with this Act, and “(ii) a petition for a variance for a device from a requirement if he determines that the methods to be used in, and the facilities and controls to be used for, the manufacture, packing, storage, and installation of the device in lieu of the methods, controls, and facilities prescribed by the requirement are sufficient to assure that the device will be safe and effective and otherwise in compliance with tills Act. An order of the Secretary approving a petition for a variance shall prescribe such conditions respecting the methods used in, and the facilities and controls used for, the manufacture, packing, storage, and installation of the device to be granted the variance under the petition as may be necessary to assure that the device will be safe and effective and otherwise in compliance with this Act. “(D) After the issuance of an order under subparagraph (B) respecting a petition, the petitioner shall have an opportunity for an informal hearing on such order. “(3) The Secretary shall establish an advisory committee for the purpose of advising and making recommendations to him with respect to regulations proposed to be promulgated under paragraph (1) (A) and the approval or disapproval of petitions submitted under Membership. paragraph (2). The advisory committee shall lie composed of nine members as follows: “(A) Three of the members shall be appointed from persons who are officers or employees of any State or local government or of the Federal Government. “(B) Two of the members shall be appointed from persons who are representative of interests of the device manufacturing industry; two of the members shall be appointed from persons who are representative of the interests of physicians and other health professionals; and two of the members shall be representative of the interests of the general public. Members of the advisory committee who are not officers or employees of the United States, while attending conferences or meetings of the committee or otherwise engaged in its business, shall be entitled to receive compensation at rates to be fixed by the Secretary, which rates may not exceed the daily equivalent of the rate in effect for grade 5 USC 5332 note. GS–18 of the General Schedule, for each day (including traveltime) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by section 5703 of title 5 of the United States Code for persons in the Government service employed intermittently. The Secretary shall designate one of the members of the advisory committee to serve as its chairman. The Secretary shall furnish the advisory committee with clerical and other assistance. Section 14 of the Federal Advisory Committee Act 5 USC app. 1. shall not apply with respect to the duration of the advisory committee established under this paragraph. “Exemption for Devices for Investigational Use “(g) (1) It is the purpose of this subsection to encourage, to the extent consistent with the protection of the public health and safety and with ethical standards, the discovery and development of useful devices intended for human use and to that end to maintain optimum freedom for scientific investigators in their pursuit of that purpose. “(2) (A) The Secretary shall, within the one hundred and twenty-day Regulation. period beginning on the date of the enactment of this section, by regulation prescribe procedures and conditions under which devices intended for human use may upon application be granted an exemption from the requirements of section 502, 510, 514, 515, 516, 519, or 706 or subsection (e) or (f) of this section or from any combination 21 USC 352, 360. Ante, pp. 546, 552, 560, 564. 21 USC 376. of such requirements to permit the investigational use of such devices by experts qualified by scientific training and experience to investigate the safety and effectiveness of such devices. “(B) The conditions prescribed pursuant to subparagraph (A) shall include the following: “(i) A requirement that an application be submitted to the Secretary before an exemption may be granted and that the application be submitted in such form and manner as the Secretary shall specify. “(ii) A requirement that the person applying for an exemption for a device assure the establishment and maintenance of such records, and the making of such reports to the Secretary of data obtained as a result of the investigational use of the device during the exemption, as the Secretary determines will enable him to assure compliance with such conditions, review the progress of the investigation, and evaluate the safety and effectiveness of the device. “(iii) Such other requirements as the Secretary may determine to be necessary for the protection of the public health and safety. “(C) Procedures and conditions prescribed pursuant to subparagraph (A) for an exemption may appropriately vary depending on (i) the scope and duration of clinical testing to be conducted under such exemption, (ii) the number of human subjects that are to be involved in such testing, (iii) the need to permit changes to be made in the device subject to the exemption during testing conducted in accordance with a clinical testing plan required under paragraph (3) (A), and (iv) whether the clinical testing of such device is for the purpose of developing data to obtain approval for the commercial distribution of such device. “(3) Procedures and conditions prescribed pursuant to paragraph (2) (A) shall require, as a condition to the exemption of any device to be the subject of testing involving human subjects, that the person applying for the exemption— “(A) submit a plan for any proposed clinical testing of the device and a report of prior investigations of the device (includ-trig, where appropriate, tests on animals) adequate to justify the proposed clinical testing— “(i) to the local institutional review committee which has been established in accordance with regulations of the Secretary to supervise clinical testing of devices in the facilities where the proposed clinical testing is to be conducted, or “(ii) to the Secretary, if— “(I) no such committee exists, or “(II) the Secretary finds that the process of review by such committee is inadequate (whether or not the plan for such testing has been approved by such committee), for review for adequacy to justify the commencement of such testing; and, unless the plan and report are submitted to the Secretary, submit to the Secretary a summary of the plan and a report of prior investigations of the device (including, where appropriate, tests on animals); “(B) promptly notify the Secretary (under such circumstances and in such manner as the Secretary prescribes) of approval by a local institutional review committee of any clinical testing plan submitted to it in accordance with subparagraph (A); “(C) in the case of a device to be distributed to investigators for testing, obtain signed agreements from each of such investigators that any testing of the device involving human subjects will be under such investigator’s supervision and in accordance with subparagraph (D) and submit such agreements to the Secretary; and “(D) assure that informed consent will be obtained from each human subject (or his representative) of proposed clinical testing involving such device, except where subject to such conditions as the Secretary may prescribe, the investigator conducting or supervising the proposed clinical testing of the device determines in writing that there exists a life threatening situation involving the human subject of such testing which necessitates the use of such device and it is not feasible to obtain informed consent from the subject and there is not sufficient time to obtain such consent from his representative. The determination required by subparagraph (D) shall be concurred in by a licensed physician who is not involved in the testing of the human subject with respect to which such determination is made unless immediate use of the device is required to save the life of the human subject of such testing and there is not sufficient time to obtain such concurrence. “(4) (A) An application, submitted in accordance with the procedures prescribed by regulations under paragraph (2), for an exemption for a device (other than an exemption from section 516) shall be deemed approved on the thirtieth day after the submission of the application to the Secretary unless on or before such day the Secretary by order disapproves the application and notifies the applicant of the disapproval of the application. “(B) The Secretary may disapprove an application only if he finds that the investigation with respect to which the application is submitted does not conform to procedures and conditions prescribed under Hearing. regulations under paragraph (2). Such a notification shall contain the order of disapproval and a complete statement of the reasons for the Secretary’s disapproval of the application and afford the applicant opportunity for an informal hearing on the disapproval order. “(5) The Secretary may by order withdraw an exemption granted under this subsection for a device if the Secretary determines that the conditions applicable to the device under this subsection for such exemption are not met. Such an order may be issued only after opportunity for an informal hearing, except that such an order may be issued before the provision of an opportunity for an informal hearing if the Secretary determines that the continuation of testing under the exemption with respect to which the order is to be issued will result in an unreasonable risk to the public health. “Release of Safety and Effectiveness Information “(h) (1) The Secretary shall promulgate regulations under which Regulations. a detailed summary of information respecting the safety and effectiveness of a device which information was submitted to the Secretary and which was the basis for— “(A) an order under section 515(d)(1)(A) approving an Ante, p. 552. application for premarket approval for the device or denying approval of such an application or an order under section 515(e) withdrawing approval of such an application for the device, “(B) an order under section 515(f)(6)(A) revoking an approved protocol for the device, an order under section 515(f) (6)(B) declaring a protocol for the device completed or not completed, or an order under section 515(f)(7) revoking the approval of the device, or “(C) an order approving an application under subsection (g) for an exemption for the device from section 516 or an order disapproving, or withdrawing approval of, an application for an exemption under such subsection for the device, shall be made available to the public upon issuance of the order. Ante, p. 560. Summaries of information made available pursuant to this paragraph respecting a device shall include information respecting any adverse effects on health of the device. “(2) The Secretary shall promulgate regulations under which each Regulations. advisory committee established under section 515(g)(2)(B) shall make available to the public a detailed summary of information respecting the safety and effectiveness of a device which information was submitted to the advisory committee and which was the basis for its recommendation to the Secretary made pursuant to section 515 (g) (2) (A). A summary of information upon which such a recommendation is based shall be made available pursuant to this paragraph only after the issuance of the order with respect to which the recommendation was made and each summary shall include information respecting any adverse effect on health of the device subject to such order. “(3) Any information respecting a device which is made available pursuant to paragraph (1) or (2) of this subsection (A) may not be used to establish the safety or effectiveness of another device for purposes of this Act by any person other than the person who submitted the information so made available, and (B) shall be made available subject to subsection (c) of this section. “Proceedings of Advisory Panels and Committees “(i) Each panel under section 513 and each advisory committee Ante, p. 540. Ante, p. 546. established under section 514(g) (5) (B) or 515(g) or under subsection (f) of this section shall make and maintain a transcript of any proceeding of the panel or committee, Each such panel and committee shall delete from any transcript made pursuant to this subsection information which under subsection (c) of this section is to be considered confidential. “Traceability Requirements “(j) No regulation under this Act may impose on a type or class of device requirements for the traceability of such type or class of device unless such requirements are necessary to assure the protection of the public health. “Research and Development “(k) The Secretary may enter into contracts for research, testing, and demonstrations respecting devices and may obtain devices for research, testing, and demonstration purposes without regard to sections 3648 and 3709 of the Revised Statutes (31 U.S.C. 529, 41 U.S.C. 5). “Transitional Provisions for Devices Considered as New Drugs or Antibiotic Drugs “(l) (1) Any device intended for human use— “(A) for which on the date of enactment of the Medical Device Amendments of 1976 (hereinafter in this subsection referred to as the ‘enactment date’) an approval of an application 21 USC 355. submitted under section 505 (b) was in effect; “(B) for which such an application was filed on or before the enactment date and with respect to which application no order of approval or refusing to approve had been issued on such date under subsection (c) or (d) of such section; “(C) for which on the enactment date an exemption under subsection (i) of such section was in effect; “(D) which is within a type of device described in subparaSraph (A), (B), or (C) and is substantially equivalent to another device within that type; “(E) which the Secretary in a notice published in the Federal Register before the enactment date has declared to be a new drug subject to section 505; or “(F) with respect to which on the enactment date an action is pending in a United States court under section 302, 303, or 304 for an alleged violation of a provision of section 301 which enforces a requirement of section 505 or for an alleged violation of section 505(a), is classified in class III unless the Secretary in response to a petition submitted under paragraph (2) has classified such device in class I or II. “(2) The manufacturer or importer of a device classified under paragraph (1) may petition the Secretary (in such form and manner as he shall prescribe) for the issuance of an order classifying the Notification. device in class I or class II. Within thirty days of the filing of such a petition, the Secretary shall notify the petitioner of any deficiencies in the petition which prevent the Secretary from making a decision Hearing. on the petition. Except as provided in paragraph (3) (D) (ii), within one hundred and eighty days after the filing of a petition under this paragraph and after affording the petitioner an opportunity for an informal hearing, the Secretary shall, after consultation with the Ante, p. 540. appropriate panel under section 513, by order either deny the petition or order the classification, in accordance with the criteria prescribed by section 513(a) (1) (A) or 513(a) (1) (B), of the device in class I or class II. “(3) (A) In the case of a device which is described in paragraph (1) (A) and which is in class III— “(i) such device shall on the enactment date be considered a device with an approved application under section 515, and Ante, p. 552. “(ii) the requirements applicable to such device before the enactment date under section 505 shall continue to apply to such 21 USC 355. device until changed by the Secretary as authorized by this Act. “(B) Tn the case of a device which is described in paragraph (1) (B) and which is in class III, an application for such device shall be considered as having been filed under section 515 on the enactment date. The period in which the Secretary shall act on such application in accordance with section 515(d) (1) shall be one hundred and eighty days from the enactment date (or such greater period as the Secretary and the applicant may agree upon after the Secretary has made the finding required by section 515 (d) (1) (B) (i)) less the number of days in the period beginning on the date an application for such device was filed under section 505 and ending on the enactment date. After the expiration of such period such device is required, unless exempt under subsection (g), to have in effect an approved application under section 515. “(C) A device which is described in paragraph (1) (C) and which is in class TH shall be considered a new drug until the expiration of the ninety-day period beginning on the date of the promulgation of regulations under subsection (g) of this section. After the expiration of such period such device is required, unless exempt under subsection (g), to have in effect an approved application under section 515. “(D) (i) Except as provided in clauses (ii) and (iii), a device which is described in subparagraph (D), (E), or (F) of paragraph (1) and which is in class III is required, unless exempt under subsection (g) of this section, to have on and after sixty days after the enactment date in effect an approved application under section 515. “(ii) If— “(I) a petition is filed under paragraph (2) for a device described in subparagraph (D), (E),or (F) of paragraph (1),or “(II) an application for premarket approval is filed under section 515 for such a device, within the sixty-day period beginning on the enactment date (or within such greater period as the Secretary, after making the finding required under section 515(d)(1)(B), and the petitioner or applicant may agree upon), the Secretary shall act on such petition or application in accordance with paragraph (2) or section 515 except that the period within which the Secretary must act on the petition or application shall be within the one hundred and twenty-day period beginning on the date the petition or application is filed. If such a petition or application is filed within such sixty-day (or greater) period, clause (i) of this subparagraph shall not apply to such device before the expiration of such one hundred and twenty-day period, or if such petition is denied or such application is denied approval, before the date of such denial, whichever occurs first. “(iii) In the case of a device which is described in subparagraph Publication in Federal Register. (E) of paragraph (1), which the Secretary in a notice published in the Federal Register after March 31, 1976, declared to be a new drug subject to section 505, and which is in class TIT— “(I) the device shall, after eighteen months after the enactment date, have in effect an approved application under section 515 unless exempt under subsection (g) of this section, and “(II) the Secretary may, during the period beginning one hundred and eighty days after the enactment date and ending eighteen months after such date, restrict the use of the device to investigational use by experts qualified by scientific training and experience to investigate the safety and effectiveness of such device, and to investigational use in accordance with the requirements applicable muter regulations under subsection (g) of this section to investigational use of devices granted an exemption under such subsection. If the requirements under subsection (g) of this section are made applicable to the investigational use of such a device, they shall be made applicable in such a manner that the device shall be made reasonably available, to physicians meeting appropriate qualifications prescribed by the Secretary. “(4) Any device intended for human use which on the enactment date was subject to the requirements of section 507 shall be subject to such requirements as follows: “(A) In the case of such a device which is classified into class I, such requirements shall apply to such device until the effective date of the regulation classifying the device into such class. “(B) In the case of such a device which is classified into class II, such requirements shall apply to such device until the effective date of a performance standard applicable to the device under Ante, p. 546. section 514. “(C) In the case of such a device which is classified into class III, such requirements shall apply to such device until the date on which the device is required to have in effect an approved Ante, p. 552. application under section 515. “state and local requirements respecting devices “Sec. 521. “General Rule (a) Except as provided in subsection (b), no State or political subdivision of a State may establish or continue in effect with respect to a device intended for human use any requirement— “(1) which is different from, or in addition to, any requirement applicable under this Act to the device, and “(2) which relates to the safety or effectiveness of the device or to any other matter included in a requirement applicable to the device under this Act. “Exempt Requirements “(b) Upon application of a State or a political subdivision thereof, the Secretary may, by regulation promulgated after notice and opportunity for an oral hearing, exempt from subsection (a), under such conditions as may be prescribed in such regulation, a requirement of such State or political subdivision applicable to a device intended for human use if— “(1) the requirement is more stringent than a requirement under this Act which would be applicable to the device if an exemption were not in effect under this subsection; or “(2) the requirement— “(A) is required by compelling local conditions, and “(B) compliance with the requirement would not cause the device to be in violation of any applicable requirement under this Act.”.

2. 1990

   Pub. L. 101–629 § 11(1) · 104 Stat. 4469

   1. Substituted · 21 U.S.C. § 360j(c)

      Pub. L. 101–629, § 11(1), substituted “from class III to class II or class I” for “under section 360c of this title from class III to class II”

   2. Inserted · 21 U.S.C. § 360j(c)

      Pub. L. 101–629, § 11(1), inserted “(1) in accordance with subsection (h), and (2)” after “except”

   Source evidence

   Code amendment note
   Subsec. (c). Pub. L. 101–629, § 11(1), substituted “from class III to class II or class I” for “under section 360c of this title from class III to class II” and inserted “(1) in accordance with subsection (h), and (2)” after “except”.

   Enacted provision · exact public law section
   (1) in subsection (c)— (A) by striking out “under section 513 from class III to class II” and inserting in lieu thereof “from class III to class II or class I”, and (B) by inserting “(1) in accordance with subsection (h), and (2)’’ after “except”, and

3. 1990

   Pub. L. 101–629 § 18(e) · 104 Stat. 4469

   Inserted · 21 U.S.C. § 360j(f)(1)(A)

   Pub. L. 101–629, § 18(e), inserted “pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device),” after “manufacture,”

   Source evidence

   Code amendment note
   Subsec. (f)(1)(A). Pub. L. 101–629, § 18(e), inserted “pre-production design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device),” after “manufacture,”.

   Enacted provision · exact public law section
   (e) Section520(f).— Section 520(f)(1)(A) (21 U.S.C. 360j(f)(1)(A)) is amended by inserting “preproduction design validation (including a process to assess the performance of a device but not including an evaluation of the safety or effectiveness of a device),” after “manufacture,”.

4. 1990

   Pub. L. 101–629 § 11(2)(A) · 104 Stat. 4469

   Substituted · 21 U.S.C. § 360j(h)(3)

   Pub. L. 101–629, § 11(2)(A), substituted “Except as provided in paragraph (4), any” for “Any”

   Source evidence

   Code amendment note
   Subsec. (h)(3). Pub. L. 101–629, § 11(2)(A), substituted “Except as provided in paragraph (4), any” for “Any”.

   Enacted provision · exact public law section
   (A) in paragraph (3), by striking out “Any” and inserting in lieu thereof “Except as provided in paragraph (4), any”, and

5. 1990

   Pub. L. 101–629 § 11(2)(B) · 104 Stat. 4469

   Added · 21 U.S.C. § 360j(h)(4)

   Pub. L. 101–629, § 11(2)(B), added par. (4)

   Source evidence

   Code amendment note
   Subsec. (h)(4). Pub. L. 101–629, § 11(2)(B), added par. (4).

   Enacted provision · exact public law section
   (B) by adding at the end the following new paragraph: “(4) (A) Any information contained in an application for premarket approval filed with the Secretary pursuant to section 515(c), including clinical and preclinical tests or studies, but excluding descriptions of methods of manufacture and product composition, that demonstrates the safety and effectiveness of a device shall be avail-able 1 year after the original application for the fourth device of a kind has been approved by the Secretary, for use by the Secretary in approving devices, or determining whether a product development protocol has been completed, under section 515, establishing a performance standard under section 514, and reclassifying devices under subsections (e) and (f) of section 513, and subsection (1)(2). The Secretary shall deem devices that incorporate the same technologies, have the same principles of operation, and are intended for the same use or uses to be within a kind of device. “(B) The Secretary, contemporaneously with the approval of the fourth device of a kind, shall publish an order in the Federal Register identifying the four devices of a kind that have been approved under section 515 and the date on which the data contained in premarket approval applications for the devices will be available to the Secretary for use, as described in subparagraph (A). “(C) The publicly available detailed summaries of information respecting the safety and effectiveness of devices required by para- graph (1)(A) shall be available for use by the Secretary as the evidentiary basis for the regulatory action described in subparagraph (A). “(D) (i) This paragraph shall become effective— Effective date. “(I) on November 15, 1990, for devices for which four devices of a kind were approved on or before December 31, 1987, and “(II) on November 15, 1991, for devices not described in subclause (I). “(ii) For each device described in clause (i)(I), the Secretary shall Federal Register, publication. publish a notice in the Federal Register setting forth the date, which shall be not earlier than 1 year after the date of the notice, that data identified in subparagraph (A) shall be available for the use of the Secretary. “(E) (i) Except as provided in clause (ii), the approval date of a device, for purposes of this paragraph, shall be the date of the letter of the Secretary to the applicant approving a device under section 515 and permitting the applicant to commercially distribute the device. “(ii) For each device described in subparagraph (D)(i)(II) for which the original application for a fourth device of a kind is approved by the Secretary before November 1, 1991, the approval date of the fourth device of a kind shall be deemed to be November 15, 1991. “(F) Any challenge to an order under subparagraph (B) shall be made not later than 30 days after the date of the Federal Register notice referred to in such subparagraph.”.

6. 1990

   Pub. L. 101–629 § 6(b)(2) · 104 Stat. 4469

   Substituted · 21 U.S.C. § 360j(i)

   Pub. L. 101–629, § 6(b)(2), substituted “section 360d(b)(5)(B)” for “section 360d(g)(5)(B)”

   Source evidence

   Code amendment note
   Subsec. (i). Pub. L. 101–629, § 6(b)(2), substituted “section 360d(b)(5)(B)” for “section 360d(g)(5)(B)”.

   Enacted provision · exact public law section
   (2) Section 520(i) (21 U.S.C. 360j(i)) is amended by striking out “514(g)(5)(B)” and inserting in lieu thereof “514(b)(5)(B)”.

7. 1990

   Pub. L. 101–629 § 3(b)(2) · 104 Stat. 4469

   Substituted · 21 U.S.C. § 360j(j)

   Pub. L. 101–629, § 3(b)(2), substituted “Except as provided in section 360i(e) of this title, no” for “No”

   Source evidence

   Code amendment note
   Subsec. (j). Pub. L. 101–629, § 3(b)(2), substituted “Except as provided in section 360i(e) of this title, no” for “No”.

   Enacted provision · exact public law section
   (2) Section 520(j) (21 U.S.C. 360j(j)) is amended by striking out “No” and inserting in lieu thereof “Except as provided in section 519(e), no”.

8. 1990

   Pub. L. 101–629 § 18(f) · 104 Stat. 4469

   Struck · 21 U.S.C. § 360j(l)(2)

   Pub. L. 101–629, § 18(f), struck out “and after affording the petitioner an opportunity for an informal hearing” after “under this paragraph”

   Source evidence

   Code amendment note
   Subsec. (l)(2). Pub. L. 101–629, § 18(f), struck out “and after affording the petitioner an opportunity for an informal hearing” after “under this paragraph”.

   Enacted provision · exact public law section
   (f) Section520(1).— Section 520(1)(2) (21 U.S.C. 360j(l)(2)) is amended by striking out “and after affording the petitioner an opportunity for an informal hearing”.

9. 1990

   Pub. L. 101–629 § 5(c)(2) · 104 Stat. 4469

   Substituted · 21 U.S.C. § 360j(l)(2)

   Pub. L. 101–629, § 5(c)(2), substituted “The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer” for “The manufacturer”

   Target inherited from the preceding amendment note.

   Source evidence

   Code amendment note
   Pub. L. 101–629, § 5(c)(2), substituted “The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer” for “The manufacturer”.

   Enacted provision · exact public law section
   (2) Section 520(1)(2) (21 U.S.C. 360j(l)(2)) is amended by striking out “The manufacturer” and inserting in lieu thereof “The Secretary may initiate the reclassification of a device classified into class III under paragraph (1) of this subsection or the manufacturer”.

10. 1990

    Pub. L. 101–629 § 4(b)(2) · 104 Stat. 4469

    Added · 21 U.S.C. § 360j(l)(5)

    Pub. L. 101–629, § 4(b)(2), added par. (5)

    Source evidence

    Code amendment note
    Subsec. (l)(5). Pub. L. 101–629, § 4(b)(2), added par. (5).

    Enacted provision · exact public law section
    (2) Section 520(1) (21 U.S.C. 360j(D) is amended by adding at the end the following: “(5) (A) Before December 1, 1991, the Secretary shall by order require manufacturers of devices described in paragraph (1), which are subject to revision of classification under subparagraph (B), to submit to the Secretary a summary of and citation to any information known or otherwise available to the manufacturers respecting the devices, including adverse safety or effectiveness information which has not been submitted under section 519. The Secretary may require a manufacturer to submit the adverse safety or effectiveness data for which a summary and citation were submitted, if such data are available to the manufacturer. “(B) Except as provided in subparagraph (C), after the issuance of an order under subparagraph (A) but before December 1, 1992, the Secretary shall publish a regulation in the Federal Register for each device which is classified in class III under paragraph (1) revising the classification of the device so that the device is classified into class I or class II, unless the regulation requires the device to remain in class III. In determining whether to revise the classification of a device or to require a device to remain in class III, the Secretary Regulations. shall apply the criteria set forth in section 513(a). Before the publication of a regulation requiring a device to remain in class III or revising its classification, the Secretary shall publish a proposed regulation respecting the classification of a device under this subparagraph and provide an opportunity for the submission of comments on any such regulation. No regulation under this subparagraph requiring a device to remain in class III or revising its classification may take effect before the expiration of 90 days from the date of the publication in the Federal Register of the proposed regulation. “(C) The Secretary may by notice published in the Federal Register extend the period prescribed by subparagraph (B) for a device for an additional period not to exceed 1 year.”.

11. 1990

    Pub. L. 101–629 § 14(a) · 104 Stat. 4469

    Added · 21 U.S.C. § 360j(m)

    Pub. L. 101–629, § 14(a), added subsec. (m)

    Source evidence

    Code amendment note
    Subsec. (m). Pub. L. 101–629, § 14(a), added subsec. (m).

    Enacted provision · exact public law section
    (a) Exemption.— Section 520 (21 U.S.C. 360j) is amended by adding at the end the following: “(m) “Humanitarian Device Exemption (1) To the extent consistent with the protection of the public health and safety and with ethical standards, it is the purpose of this subsection to encourage the discovery and use of devices in-tended to benefit patients in the treatment and diagnosis of diseases or conditions that affect fewer than 4,000 individuals in the United States. “(2) The Secretary may grant a request for an exemption from the effectiveness requirements of sections 514 and 515 for a device for which the Secretary finds that— “(A) the device is designed to treat or diagnose a disease or condition that affects fewer than 4,000 individuals in the United States, “(B) the device would not be available to a person with a disease or condition referred to in subparagraph (A) unless the Secretary grants such an exemption and there is no comparable device, other than under this exemption, available to treat or diagnose such disease or condition, and “(C) the device will not expose patients to an unreasonable or significant risk of illness or injury and the probable benefit to health from the use of the device outweighs the risk of injury or illness from its use, taking into account the probable risks and benefits of currently available devices or alternative forms of treatment. “(3) No person granted an exemption under paragraph (2) with respect to a device may sell the device for an amount that exceeds the costs of research and development, fabrication, and distribution of the device. “(4) Devices granted an exemption under paragraph (2) may only be used— “(A) in facilities that have established, in accordance with regulations of the Secretary, a local institutional review committee to supervise clinical testing of devices in the facilities, and “(B) if, before the use of a device, an institutional review committee approves the use in the treatment or diagnosis of a disease or condition referred to in paragraph (2)(A). “(5) An exemption under paragraph (2) shall be for a term of 18 months and may only be initially granted in the 5-year period beginning on the date regulations under paragraph (6) take effect. The Secretary may extend such an exemption for a period of 18 months if the Secretary is able to make the findings set forth in paragraph (2) and if the applicant supplies information demonstrating compliance with paragraph (3). An exemption may be extended more than once and may be extended after the expiration of such 5-year period. “(6) Within one year of the date of the enactment of this subsection, Regulations. the Secretary shall issue regulations to implement this subsection.”.

12. 1992

    Prescription Drug User Fee Act of 1992

    Pub. L. 102–571 title I § 107(10) · 106 Stat. 4491

    Substituted · 21 U.S.C. § 360j(g)(2)(A)

    Pub. L. 102–571 substituted “379e” for “376”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(A). Pub. L. 102–571 substituted “379e” for “376”.

    Enacted provision · exact public law section
    (10) Section 520(g)(2)(A) (21 U.S.C. 360j(g)(2)(A)) is amended by striking out “706” and by inserting in lieu thereof “721”.

13. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 410(a) · 111 Stat. 2296

    Added · 21 U.S.C. § 360j(f)(1)(B)(iii)

    Pub. L. 105–115, § 410(a), added cl. (iii)

    Source evidence

    Code amendment note
    Subsec. (f)(1)(B)(iii). Pub. L. 105–115, § 410(a), added cl. (iii).

    Enacted provision · exact public law section
    (a) Good Manufacturing Practice Requirements.— Section 520(f)(1)(B) (21 U.S.C. 360j(f)(1)(B)) is amended— (1) in clause (i), by striking “, and” at the end and inserting a semicolon; (2) in clause (ii), by striking the period and inserting “; and”; and (3) by inserting after clause (ii) the following: “(iii) ensure that such regulation conforms, to the extent practicable, with internationally recognized standards defining quality systems, or parts of the standards, for medical devices.”.

14. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 201(a) · 111 Stat. 2296

    Added · 21 U.S.C. § 360j(g)(6); 21 U.S.C. § 360j(g)(7)

    Pub. L. 105–115, § 201(a), added pars. (6) and (7)

    Source evidence

    Code amendment note
    Subsec. (g)(6), (7). Pub. L. 105–115, § 201(a), added pars. (6) and (7).

    Enacted provision · exact public law section
    (a) In General.— Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end the following: “(6) (A) Not later than 1 year after the date of the enactment of the Food and Drug Administration Modernization Act of 1997, the Secretary shall by regulation establish, with respect to a device for which an exemption under this subsection is in effect, procedures and conditions that, without requiring an additional approval of an application for an exemption or the approval of a supplement to such an application, permit— “(i) developmental changes in the device (including manufacturing changes) that do not constitute a significant change in design or in basic principles of operation and that are made in response to information gathered during the course of an investigation; and “(ii) changes or modifications to clinical protocols that do not affect— “(I) the validity of data or information resulting from the completion of an approved protocol, or the relationship of likely patient risk to benefit relied upon to approve a protocol; “(II) the scientific soundness of an investigational plan submitted under paragraph (3)(A); or “(III) the rights, safety, or welfare of the human subjects involved in the investigation. “(B) Regulations under subparagraph (A) shall provide that a change or modification described in such subparagraph may be made if— “(i) the sponsor of the investigation determines, on the basis of credible information (as defined by the Secretary) that the applicable conditions under subparagraph (A) are met; and “(ii) the sponsor submits to the Secretary, not later than 5 days after making the change or modification, a notice of the change or modification. “(7) (A) In the case of a person intending to investigate the safety or effectiveness of a class III device or any implantable device, the Secretary shall ensure that the person has an opportunity, prior to submitting an application to the Secretary or to an institutional review committee, to submit to the Secretary, for review, an investigational plan (including a clinical protocol). If the applicant submits a written request for a meeting with the Secretary regarding such review, the Secretary shall, not later than 30 days after receiving the request, meet with the applicant for the purpose of reaching agreement regarding the investigational plan (including a clinical protocol). The written request shall include a detailed description of the device, a detailed description of the proposed conditions of use of the device, a proposed plan (including a clinical protocol) for determining whether there is a reasonable assurance of effectiveness, and, if available, information regarding the expected performance from the device. “(B) Any agreement regarding the parameters of an investigational plan (including a clinical protocol) that is reached between the Secretary and a sponsor or applicant shall be reduced to writing and made part of the administrative record by the Secretary. Any such agreement shall not be changed, except— “(i) with the written agreement of the sponsor or applicant; or “(ii) pursuant to a decision, made in accordance with subparagraph (C) by the director of the office in which the device involved is reviewed, that a substantial scientific issue essential to determining the safety or effectiveness of the device involved has been identified. “(C) A decision under subparagraph (B)(ii) by the director shall be in writing, and may be made only after the Secretary has provided to the sponsor or applicant an opportunity for a meeting at which the director and the sponsor or applicant are present and at which the director documents the scientific issue involved.”.

15. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 216(a)(1) · 111 Stat. 2296

    Amended · 21 U.S.C. § 360j(h)(4)

    Pub. L. 105–115, § 216(a)(1), amended par. (4) generally. Prior to amendment, par. (4) related to premarket approval of devices

    Source evidence

    Code amendment note
    Subsec. (h)(4). Pub. L. 105–115, § 216(a)(1), amended par. (4) generally. Prior to amendment, par. (4) related to premarket approval of devices.

    Enacted provision · exact public law section
    (1) In general.— Section 520(h)(4) (21 U.S.C. 360j(h)(4)) is amended to read as follows: “(4) (A) Any information contained in an application for premarket approval filed with the Secretary pursuant to section 515(c) (including information from clinical and preclinical tests or studies that demonstrate the safety and effectiveness of a device, but excluding descriptions of methods of manufacture and product composition and other trade secrets) shall be available, 6 years after the application has been approved by the Secretary, for use by the Secretary in— “(i) approving another device; “(ii) determining whether a product development protocol has been completed, under section 515 for another device; “(iii) establishing a performance standard or special control under this Act; or “(iv) classifying or reclassifying another device under section 513 and subsection (1)(2). “(B) The publicly available detailed summaries of information respecting the safety and effectiveness of devices required by paragraph (1)(A) shall be available for use by the Secretary as the evidentiary basis for the agency actions described in subparagraph (A).”.

16. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 125(b)(2)(E) · 111 Stat. 2296

    Struck · 21 U.S.C. § 360j(l)

    Pub. L. 105–115, § 125(b)(2)(E), struck out “or antibiotic drugs” after “new drugs” in heading

    Source evidence

    Code amendment note
    Subsec. (l). Pub. L. 105–115, § 125(b)(2)(E), struck out “or antibiotic drugs” after “new drugs” in heading.

    Enacted provision · exact public law section
    (E) Section 520(1) (21 U.S.C. 360j(l)) is amended by striking paragraph (4) and by striking “or Antibiotic Drugs” in the subsection heading.

17. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 125(b)(2)(E) · 111 Stat. 2296

    Struck · 21 U.S.C. § 360j(l)(4)

    Pub. L. 105–115, § 125(b)(2)(E), struck out par. (4) which read as follows: “Any device intended for human use which on the enactment date was subject to the requirements of section 357 of this title shall be subject to such requirements as follows:

    Source evidence

    Code amendment note
    Subsec. (l)(4). Pub. L. 105–115, § 125(b)(2)(E), struck out par. (4) which read as follows: “Any device intended for human use which on the enactment date was subject to the requirements of section 357 of this title shall be subject to such requirements as follows:

    “(A) In the case of such a device which is classified into class I, such requirements shall apply to such device until the effective date of the regulation classifying the device into such class. “(B) In the case of such a device which is classified into class II, such requirements shall apply to such device until the effective date of a performance standard applicable to the device under section 360d of this title. “(C) In the case of such a device which is classified into class III, such requirements shall apply to such device until the date on which the device is required to have in effect an approved application under section 360e of this title.”

    Enacted provision · exact public law section
    (E) Section 520(1) (21 U.S.C. 360j(l)) is amended by striking paragraph (4) and by striking “or Antibiotic Drugs” in the subsection heading.

18. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 203(1) · 111 Stat. 2296

    Inserted · 21 U.S.C. § 360j(m)(2)

    Pub. L. 105–115, § 203(1), inserted at end “The request shall be in the form of an application submitted to the Secretary. Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.”

    Source evidence

    Code amendment note
    Subsec. (m)(2). Pub. L. 105–115, § 203(1), inserted at end “The request shall be in the form of an application submitted to the Secretary. Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.”

    Enacted provision · exact public law section
    (1) in paragraph (2), by adding after and below subparagraph (C) the following sentences: “The request shall be in the form of an application submitted to the Secretary. Not later than 75 days after the date of the receipt of the application, the Secretary shall issue an order approving or denying the application.”;

19. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 203(2)(B) · 111 Stat. 2296

    Inserted · 21 U.S.C. § 360j(m)(4)

    Pub. L. 105–115, § 203(2)(B), inserted at end “In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the local institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.”

    Source evidence

    Code amendment note
    Subsec. (m)(4). Pub. L. 105–115, § 203(2)(B), inserted at end “In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the local institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.”

    Enacted provision · exact public law section
    (B) by adding after and below subparagraph (B) the following: “In a case described in subparagraph (B) in which a physician uses a device without an approval from an institutional review committee, the physician shall, after the use of the device, notify the chairperson of the local institutional review committee of such use. Such notification shall include the identification of the patient involved, the date on which the device was used, and the reason for the use.”;

20. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 203(2)(A) · 111 Stat. 2296

    Inserted · 21 U.S.C. § 360j(m)(4)(B)

    Pub. L. 105–115, § 203(2)(A), inserted before period at end “, unless a physician determines in an emergency situation that approval from a local institutional review committee can not be obtained in time to prevent serious harm or death to a patient”

    Source evidence

    Code amendment note
    Subsec. (m)(4)(B). Pub. L. 105–115, § 203(2)(A), inserted before period at end “, unless a physician determines in an emergency situation that approval from a local institutional review committee can not be obtained in time to prevent serious harm or death to a patient”.

    Enacted provision · exact public law section
    (A) in subparagraph (B), by inserting after “(2)(A)” the following: “, unless a physician determines in an emergency situation that approval from a local institutional review committee can not be obtained in time to prevent serious harm or death to a patient”; and

21. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 203(3) · 111 Stat. 2296

    Amended · 21 U.S.C. § 360j(m)(5)

    Pub. L. 105–115, § 203(3), amended par. (5) generally. Prior to amendment, par. (5) read as follows: “An exemption under paragraph (2) shall be for a term of 18 months and may only be initially granted in the 5-year period beginning on the date regulations under paragraph (6) take effect. The Secretary may extend such an exemption for a period of 18 months if the Secretary is able to make the findings set forth in paragraph (2) and if the applicant supplies information demonstrating compliance with paragraph (3). An exemption may be extended more than once and may be extended after the expiration of such 5-year period.”

    Source evidence

    Code amendment note
    Subsec. (m)(5). Pub. L. 105–115, § 203(3), amended par. (5) generally. Prior to amendment, par. (5) read as follows: “An exemption under paragraph (2) shall be for a term of 18 months and may only be initially granted in the 5-year period beginning on the date regulations under paragraph (6) take effect. The Secretary may extend such an exemption for a period of 18 months if the Secretary is able to make the findings set forth in paragraph (2) and if the applicant supplies information demonstrating compliance with paragraph (3). An exemption may be extended more than once and may be extended after the expiration of such 5-year period.”

    Enacted provision · exact public law section
    (3) by amending paragraph (5) to read as follows: “(5) The Secretary may require a person granted an exemption under paragraph (2) to demonstrate continued compliance with the requirements of this subsection if the Secretary believes such demonstration to be necessary to protect the public health or if the Secretary has reason to believe that the criteria for the exemption are no longer met.”; and

22. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 203(4) · 111 Stat. 2296

    Amended · 21 U.S.C. § 360j(m)(6)

    Pub. L. 105–115, § 203(4), amended par. (6) generally. Prior to amendment, par. (6) read as follows: “Within one year of November 28, 1990, the Secretary shall issue regulations to implement this subsection.”

    Source evidence

    Code amendment note
    Subsec. (m)(6). Pub. L. 105–115, § 203(4), amended par. (6) generally. Prior to amendment, par. (6) read as follows: “Within one year of November 28, 1990, the Secretary shall issue regulations to implement this subsection.”

    Enacted provision · exact public law section
    (4) by amending paragraph (6) to read as follows: “(6) The Secretary may suspend or withdraw an exemption from the effectiveness requirements of sections 514 and 515 for a humanitarian device only after providing notice and an opportunity for an informal hearing.”.

23. 2005

    Pub. L. 109–96 § 1 · 119 Stat. 2119

    Added · 21 U.S.C. § 360j(n)

    Pub. L. 109–96 added subsec. (n)

    Source evidence

    Code amendment note
    Subsec. (n). Pub. L. 109–96 added subsec. (n).

    Enacted provision · exact public law section
    SECTION 1. REGULATION OF CERTAIN ARTICLES AS MEDICAL DEVICES.   Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amended by adding at the end the following subsection: “Regulation of Contact Lens as Devices “(n) (1) All contact lenses shall be deemed to be devices under section 201(h). “(2) Paragraph (1) shall not be construed as bearing on or being relevant to the question of whether any product other than a contact lens is a device as defined by section 201(h) or a drug as defined by section 201(g).” .

24. 2007

    Food and Drug Administration Amendments Act of 2007

    Pub. L. 110–85 § 801(b)(3)(E) · 121 Stat. 823

    Inserted · 21 U.S.C. § 360j(m)(2)

    Pub. L. 110–85, § 801(b)(3)(E), inserted before period at end of first sentence of concluding provisions “and such application shall include the certification required under section 282(j)(5)(B) of title 42 (which shall not be considered an element of such application)”

    Source evidence

    Code amendment note
    Subsec. (m)(2). Pub. L. 110–85, § 801(b)(3)(E), inserted before period at end of first sentence of concluding provisions “and such application shall include the certification required under section 282(j)(5)(B) of title 42 (which shall not be considered an element of such application)”.

    Enacted provision · exact public law section
    (E) Humanitarian device exemption.— Section 520(m)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e(c)) 21 USC 360j. is amended in the first sentence in the matter following subparagraph (C), by inserting at the end before the period “and such application shall include the certification required under section 402(j)(5)(B) of the Public Health Service Act (which shall not be considered an element of such application)”.

25. 2007

    Pediatric Medical Device Safety and Improvement Act of 2007

    Pub. L. 110–85 § 303(a)(1) · 121 Stat. 823

    Substituted · 21 U.S.C. § 360j(m)(3)

    Pub. L. 110–85, § 303(a)(1), substituted “Except as provided in paragraph (6), no” for “No”

    Source evidence

    Code amendment note
    Subsec. (m)(3). Pub. L. 110–85, § 303(a)(1), substituted “Except as provided in paragraph (6), no” for “No”.

    Enacted provision · exact public law section
    (1) in paragraph (3), by striking “No” and inserting “Except as provided in paragraph (6), no”;

26. 2007

    Pediatric Medical Device Safety and Improvement Act of 2007

    Pub. L. 110–85 § 303(a)(2) · 121 Stat. 823

    1. Inserted · 21 U.S.C. § 360j(m)(5)

       Pub. L. 110–85, § 303(a)(2), inserted “, if the Secretary has reason to believe that the requirements of paragraph (6) are no longer met,” after “public health”

    2. Inserted · 21 U.S.C. § 360j(m)(5)

       Pub. L. 110–85, § 303(a)(2), inserted at end “If the person granted an exemption under paragraph (2) fails to demonstrate continued compliance with the requirements of this subsection, the Secretary may suspend or withdraw the exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing.”

    Source evidence

    Code amendment note
    Subsec. (m)(5). Pub. L. 110–85, § 303(a)(2), inserted “, if the Secretary has reason to believe that the requirements of paragraph (6) are no longer met,” after “public health” and inserted at end “If the person granted an exemption under paragraph (2) fails to demonstrate continued compliance with the requirements of this subsection, the Secretary may suspend or withdraw the exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing.”

    Enacted provision · exact public law section
    (2) in paragraph (5)— (A) by inserting “, if the Secretary has reason to believe that the requirements of paragraph (6) are no longer met,” after “public health”; and (B) by adding at the end the following: “If the person granted an exemption under paragraph (2) fails to demonstrate continued compliance with the requirements of this subsection, the Secretary may suspend or withdraw the exemption from the effectiveness requirements of sections 514 and 515 for a humanitarian device only after providing notice and an opportunity for an informal hearing.”; and

27. 2007

    Pediatric Medical Device Safety and Improvement Act of 2007

    Pub. L. 110–85 § 303(a)(3) · 121 Stat. 823

    1. Added · 21 U.S.C. § 360j(m)(6)(8)

       Pub. L. 110–85, § 303(a)(3), added pars. (6) to (8)

    2. Struck · 21 U.S.C. § 360j(m)(6)(8)

       Pub. L. 110–85, § 303(a)(3), struck out former par. (6) which read as follows: “The Secretary may suspend or withdraw an exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing.”

    Source evidence

    Code amendment note
    Subsec. (m)(6) to (8). Pub. L. 110–85, § 303(a)(3), added pars. (6) to (8) and struck out former par. (6) which read as follows: “The Secretary may suspend or withdraw an exemption from the effectiveness requirements of sections 360d and 360e of this title for a humanitarian device only after providing notice and an opportunity for an informal hearing.”

    Enacted provision · exact public law section
    (3) by striking paragraph (6) and inserting after paragraph (5) the following new paragraphs: “(6) (A) Except as provided in subparagraph (D), the prohibition in paragraph (3) shall not apply with respect to a person granted an exemption under paragraph (2) if each of the following conditions apply: “(i) (I) The device with respect to which the exemption is granted is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs. “(II) The device was not previously approved under this subsection for the pediatric patients or the pediatric subpopulation described in subclause (I) prior to the date of the enactment of the Pediatric Medical Device Safety and Improvement Act of 2007. “(ii) During any calendar year, the number of such devices distributed during that year does not exceed the annual distribution number specified by the Secretary when the Secretary grants such exemption. The annual distribution number shall be based on the number of individuals affected by the disease or condition that such device is intended to treat, diagnose, or cure, and of that number, the number of individuals likely to use the device, and the number of devices reasonably necessary to treat such individuals. In no case shall the annual distribution number exceed the number identified in paragraph (2)(A). “(iii) Notification. Such person immediately notifies the Secretary if the number of such devices distributed during any calendar year exceeds the annual distribution number referred to in clause (ii). “(iv) Deadline. The request for such exemption is submitted on or before October 1, 2012. “(B) The Secretary may inspect the records relating to the number of devices distributed during any calendar year of a person granted an exemption under paragraph (2) for which the prohibition in paragraph (3) does not apply. “(C) A person may petition the Secretary to modify the annual distribution number specified by the Secretary under subparagraph (A)(ii) with respect to a device if additional information on the number of individuals affected by the disease or condition arises, and the Secretary may modify such number but in no case shall the annual distribution number exceed the number identified in paragraph (2)(A). “(D) Applicability. If a person notifies the Secretary, or the Secretary determines through an inspection under subparagraph (B), that the number of devices distributed during any calendar year exceeds the annual distribution number, as required under subparagraph (A)(iii), and modified under subparagraph (C), if applicable, then the prohibition in paragraph (3) shall apply with respect to such person for such device for any sales of such device after such notification. “(E) (i) In this subsection, the term ‘pediatric patients’ means patients who are 21 years of age or younger at the time of the diagnosis or treatment. “(ii) In this subsection, the term ‘pediatric subpopulation’ means 1 of the following populations: “(I) Neonates. “(II) Infants. “(III) Children. “(IV) Adolescents. “(7) The Secretary shall refer any report of an adverse event regarding a device for which the prohibition under paragraph (3) does not apply pursuant to paragraph (6)(A) that the Secretary receives to the Office of Pediatric Therapeutics, established under section 6 of the Best Pharmaceuticals for Children Act (Public Law 107–109). In considering the report, the Director of the Office of Pediatric Therapeutics, in consultation with experts in the Center for Devices and Radiological Health, shall provide for periodic review of the report by the Pediatric Advisory Committee, including obtaining any recommendations of such committee regarding whether the Secretary should take action under this Act in response to the report. “(8) Annual review. The Secretary, acting through the Office of Pediatric Therapeutics and the Center for Devices and Radiological Health, shall provide for an annual review by the Pediatric Advisory Committee of all devices described in paragraph (6) to ensure that the exemption under paragraph (2) remains appropriate for the pediatric populations for which it is granted.” .

28. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 617 · 126 Stat. 993

    Amended · 21 U.S.C. § 360j(b)

    Pub. L. 112–144, § 617, amended subsec. (b) generally. Prior to amendment, subsec. (b) related to custom devices

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 112–144, § 617, amended subsec. (b) generally. Prior to amendment, subsec. (b) related to custom devices.

    Enacted provision · exact public law section
    SEC. 617. CUSTOM DEVICES.   Section 520(b) (21 U.S.C. 360j(b)) is amended to read as follows: “(b) Custom Devices.— “(1) In general.— The requirements of sections 514 and 515 shall not apply to a device that— “(A) is created or modified in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing); “(B) in order to comply with an order described in subparagraph (A), necessarily deviates from an otherwise applicable performance standard under section 514 or requirement under section 515; “(C) is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution; “(D) is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat; “(E) (i) is intended to meet the special needs of such physician or dentist (or other specially qualified person so designated) in the course of the professional practice of such physician or dentist (or other specially qualified person so designated); or “(ii) is intended for use by an individual patient named in such order of such physician or dentist (or other specially qualified person so designated); “(F) is assembled from components or manufactured and finished on a case-by-case basis to accommodate the unique needs of individuals described in clause (i) or (ii) of subparagraph (E); and “(G) may have common, standardized design characteristics, chemical and material compositions, and manufacturing processes as commercially distributed devices. “(2) Limitations.— Applicability. Paragraph (1) shall apply to a device only if— “(A) such device is for the purpose of treating a sufficiently rare condition, such that conducting clinical investigations on such device would be impractical; “(B) production of such device under paragraph (1) is limited to no more than 5 units per year of a particular device type, provided that such replication otherwise complies with this section; and “(C) Notification. Deadline. the manufacturer of such device notifies the Secretary on an annual basis, in a manner prescribed by the Secretary, of the manufacture of such device. “(3) Guidance.— Deadline. Not later than 2 years after the date of enactment of this section, the Secretary shall issue final guidance on replication of multiple devices described in paragraph (2)(B).” .

29. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 601(1) · 126 Stat. 993

    Inserted · 21 U.S.C. § 360j(g)(2)(B)(ii)

    Pub. L. 112–144, § 601(1), inserted “safety or effectiveness” before “data obtained”

    Source evidence

    Code amendment note
    Subsec. (g)(2)(B)(ii). Pub. L. 112–144, § 601(1), inserted “safety or effectiveness” before “data obtained”.

    Enacted provision · exact public law section
    (1) in paragraph (2)(B)(ii), by inserting “safety or effectiveness” before “data obtained”; and

30. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 601(2) · 126 Stat. 993

    Added · 21 U.S.C. § 360j(g)(4)(C)

    Pub. L. 112–144, § 601(2), added subpar. (C)

    Source evidence

    Code amendment note
    Subsec. (g)(4)(C). Pub. L. 112–144, § 601(2), added subpar. (C).

    Enacted provision · exact public law section
    (2) in paragraph (4), by adding at the end the following: “(C) Consistent with paragraph (1), the Secretary shall not disapprove an application under this subsection because the Secretary determines that— “(i) the investigation may not support a substantial equivalence or de novo classification determination or approval of the device; “(ii) the investigation may not meet a requirement, including a data requirement, relating to the approval or clearance of a device; or “(iii) an additional or different investigation may be necessary to support clearance or approval of the device.” .

31. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 606 · 126 Stat. 993

    Added · 21 U.S.C. § 360j(g)(8)

    Pub. L. 112–144, § 606, added par. (8)

    Source evidence

    Code amendment note
    Subsec. (g)(8). Pub. L. 112–144, § 606, added par. (8).

    Enacted provision · exact public law section
    SEC. 606. CLINICAL HOLDS ON INVESTIGATIONAL DEVICE EXEMPTIONS.   Section 520(g) (21 U.S.C. 360j(g)) is amended by adding at the end the following: “(8) (A) At any time, the Secretary may prohibit the sponsor of an investigation from conducting the investigation (referred to in this paragraph as a ‘clinical hold’) if the Secretary makes a determination described in subparagraph (B). The Secretary shall specify the basis for the clinical hold, including the specific information available to the Secretary which served as the basis for such clinical hold, and confirm such determination in writing. “(B) Determination. For purposes of subparagraph (A), a determination described in this subparagraph with respect to a clinical hold is a determination that— “(i) the device involved represents an unreasonable risk to the safety of the persons who are the subjects of the clinical investigation, taking into account the qualifications of the clinical investigators, information about the device, the design of the clinical investigation, the condition for which the device is to be investigated, and the health status of the subjects involved; or “(ii) the clinical hold should be issued for such other reasons as the Secretary may by regulation establish. “(C) Decision. Deadline. Any written request to the Secretary from the sponsor of an investigation that a clinical hold be removed shall receive a decision, in writing and specifying the reasons therefor, within 30 days after receipt of such request. Any such request shall include sufficient information to support the removal of such clinical hold.” .

32. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 613(a)(1)(A)(i) · 126 Stat. 993

    1. Added · 21 U.S.C. § 360j(m)(6)(A)(i)

       Pub. L. 112–144, § 613(a)(1)(A)(i), added cl. (i)

    2. Struck · 21 U.S.C. § 360j(m)(6)(A)(i)

       Pub. L. 112–144, § 613(a)(1)(A)(i), struck out former cl. (i) which read as follows:

    Source evidence

    Code amendment note
    Subsec. (m)(6)(A)(i). Pub. L. 112–144, § 613(a)(1)(A)(i), added cl. (i) and struck out former cl. (i) which read as follows:

    “(i)(I) The device with respect to which the exemption is granted is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs. “(II) The device was not previously approved under this subsection for the pediatric patients or the pediatric subpopulation described in subclause (I) prior to September 27, 2007.”

    Enacted provision · exact public law section
    (i) by striking clause (i) and inserting the following: “(i) The device with respect to which the exemption is granted— “(I) is intended for the treatment or diagnosis of a disease or condition that occurs in pediatric patients or in a pediatric subpopulation, and such device is labeled for use in pediatric patients or in a pediatric subpopulation in which the disease or condition occurs; or “(II) is intended for the treatment or diagnosis of a disease or condition that does not occur in pediatric patients or that occurs in pediatric patients in such numbers that the development of the device for such patients is impossible, highly impracticable, or unsafe.” ; and

33. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 613(a)(1)(A)(ii) · 126 Stat. 993

    1. Added · 21 U.S.C. § 360j(m)(6)(A)(ii)

       Pub. L. 112–144, § 613(a)(1)(A)(ii), added cl. (ii)

    2. Struck · 21 U.S.C. § 360j(m)(6)(A)(ii)

       Pub. L. 112–144, § 613(a)(1)(A)(ii), struck out former cl. (ii) which read as follows: “During any calendar year, the number of such devices distributed during that year does not exceed the annual distribution number specified by the Secretary when the Secretary grants such exemption. The annual distribution number shall be based on the number of individuals affected by the disease or condition that such device is intended to treat, diagnose, or cure, and of that number, the number of individuals likely to use the device, and the number of devices reasonably necessary to treat such individuals. In no case shall the annual distribution number exceed the number identified in paragraph (2)(A).”

    Source evidence

    Code amendment note
    Subsec. (m)(6)(A)(ii). Pub. L. 112–144, § 613(a)(1)(A)(ii), added cl. (ii) and struck out former cl. (ii) which read as follows: “During any calendar year, the number of such devices distributed during that year does not exceed the annual distribution number specified by the Secretary when the Secretary grants such exemption. The annual distribution number shall be based on the number of individuals affected by the disease or condition that such device is intended to treat, diagnose, or cure, and of that number, the number of individuals likely to use the device, and the number of devices reasonably necessary to treat such individuals. In no case shall the annual distribution number exceed the number identified in paragraph (2)(A).”

    Enacted provision · exact public law section
    (ii) by striking clause (ii) and inserting the following: “(ii) During any calendar year, the number of such devices distributed during that year under each exemption granted under this subsection does not exceed the annual distribution number for such device. Definition. In this paragraph, the term ‘annual distribution number’ means the number of such devices reasonably needed to treat, diagnose, or cure a population of 4,000 individuals in the United States. Determination. The Secretary shall determine the annual distribution number when the Secretary grants such exemption.” ; and

34. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 507(c) · 126 Stat. 993

    Substituted · 21 U.S.C. § 360j(m)(6)(A)(iv)

    Pub. L. 112–144, § 507(c), substituted “2017” for “2012”

    Source evidence

    Code amendment note
    Subsec. (m)(6)(A)(iv). Pub. L. 112–144, § 507(c), substituted “2017” for “2012”.

    Enacted provision · exact public law section
    (c) Humanitarian Device Exemption Extension.— Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking “2012” and inserting “2017”.

35. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 613(a)(1)(B) · 126 Stat. 993

    Amended · 21 U.S.C. § 360j(m)(6)(C)

    Pub. L. 112–144, § 613(a)(1)(B), amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: “A person may petition the Secretary to modify the annual distribution number specified by the Secretary under subparagraph (A)(ii) with respect to a device if additional information on the number of individuals affected by the disease or condition arises, and the Secretary may modify such number but in no case shall the annual distribution number exceed the number identified in paragraph (2)(A).”

    Source evidence

    Code amendment note
    Subsec. (m)(6)(C). Pub. L. 112–144, § 613(a)(1)(B), amended subpar. (C) generally. Prior to amendment, subpar. (C) read as follows: “A person may petition the Secretary to modify the annual distribution number specified by the Secretary under subparagraph (A)(ii) with respect to a device if additional information on the number of individuals affected by the disease or condition arises, and the Secretary may modify such number but in no case shall the annual distribution number exceed the number identified in paragraph (2)(A).”

    Enacted provision · exact public law section
    (B) by amending subparagraph (C) to read as follows: “(C) A person may petition the Secretary to modify the annual distribution number determined by the Secretary under subparagraph (A)(ii) with respect to a device if additional information arises, and the Secretary may modify such annual distribution number.” ;

36. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 613(a)(2) · 126 Stat. 993

    Substituted · 21 U.S.C. § 360j(m)(7)

    Pub. L. 112–144, § 613(a)(2), substituted “regarding a device described in paragraph (6)(A)(i)(I)” for “regarding a device”

    Source evidence

    Code amendment note
    Subsec. (m)(7). Pub. L. 112–144, § 613(a)(2), substituted “regarding a device described in paragraph (6)(A)(i)(I)” for “regarding a device”.

    Enacted provision · exact public law section
    (2) in paragraph (7), by striking “regarding a device” and inserting “regarding a device described in paragraph (6)(A)(i)(I)”; and

37. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 613(a)(3) · 126 Stat. 993

    Substituted · 21 U.S.C. § 360j(m)(8)

    Pub. L. 112–144, § 613(a)(3), substituted “of all devices described in paragraph (6)(A)(i)(I)” for “of all devices described in paragraph (6)”

    Source evidence

    Code amendment note
    Subsec. (m)(8). Pub. L. 112–144, § 613(a)(3), substituted “of all devices described in paragraph (6)(A)(i)(I)” for “of all devices described in paragraph (6)”.

    Enacted provision · exact public law section
    (3) in paragraph (8), by striking “of all devices described in paragraph (6)” and inserting “of all devices described in paragraph (6)(A)(i)(I)”.

38. 2016

    21st Century Cures Act

    Pub. L. 114–255 § 3024(a)(2) · 130 Stat. 1033

    Substituted · 21 U.S.C. § 360j(g)(3)

    Pub. L. 114–255, § 3024(a)(2), substituted “subparagraph (D)(ii)” for “subparagraph (D)” in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (g)(3). Pub. L. 114–255, § 3024(a)(2), substituted “subparagraph (D)(ii)” for “subparagraph (D)” in concluding provisions.

    Enacted provision · exact public law section
    (2) in the matter following subparagraph (D), by striking “subparagraph (D)” and inserting “subparagraph (D)(ii)”.

39. 2016

    21st Century Cures Act

    Pub. L. 114–255 § 3056(1)(A) · 130 Stat. 1033

    Struck · 21 U.S.C. § 360j(g)(3)(A)(i)

    Pub. L. 114–255, § 3056(1)(A), struck out “local” before “institutional review committee” and “which has been” before “established in accordance with”

    Source evidence

    Code amendment note
    Subsec. (g)(3)(A)(i). Pub. L. 114–255, § 3056(1)(A), struck out “local” before “institutional review committee” and “which has been” before “established in accordance with”.

    Enacted provision · exact public law section
    (A) in subparagraph (A)(i)— (i) by striking “local”; and (ii) by striking “which has been”; and

40. 2016

    21st Century Cures Act

    Pub. L. 114–255 § 3056(1)(B) · 130 Stat. 1033

    Substituted · 21 U.S.C. § 360j(g)(3)(B)

    Pub. L. 114–255, § 3056(1)(B), substituted “an institutional” for “a local institutional”

    Source evidence

    Code amendment note
    Subsec. (g)(3)(B). Pub. L. 114–255, § 3056(1)(B), substituted “an institutional” for “a local institutional”.

    Enacted provision · exact public law section
    (B) in subparagraph (B), by striking “a local institutional” and inserting “an institutional”; and

41. 2016

    21st Century Cures Act

    Pub. L. 114–255 § 3024(a)(1) · 130 Stat. 1033

    1. Substituted · 21 U.S.C. § 360j(g)(3)(D)

       Pub. L. 114–255, § 3024(a)(1), substituted “except where, subject to such conditions as the Secretary may prescribe—” for “except where subject to such conditions as the Secretary may prescribe,”

    2. Added · 21 U.S.C. § 360j(g)(3)(D)

       Pub. L. 114–255, § 3024(a)(1), added cl. (i)

    3. Inserted · 21 U.S.C. § 360j(g)(3)(D)

       Pub. L. 114–255, § 3024(a)(1), inserted cl. (ii) designation before “the investigator”

    Source evidence

    Code amendment note
    Subsec. (g)(3)(D). Pub. L. 114–255, § 3024(a)(1), substituted “except where, subject to such conditions as the Secretary may prescribe—” for “except where subject to such conditions as the Secretary may prescribe,”, added cl. (i), and inserted cl. (ii) designation before “the investigator”.

    Enacted provision · exact public law section
    (1) in subparagraph (D), by striking “except where subject to such conditions as the Secretary may prescribe, the investigator” and inserting the following: “except where, subject to such conditions as the Secretary may prescribe— “(i) the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject; or “(ii) the investigator” ; and

42. 2016

    21st Century Cures Act

    Pub. L. 114–255 § 3038(b)(1) · 130 Stat. 1033

    Substituted · 21 U.S.C. § 360j(h)(4)(A)

    Pub. L. 114–255, § 3038(b)(1), substituted “Subject to subparagraph (C), any information” for “Any information” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (h)(4)(A). Pub. L. 114–255, § 3038(b)(1), substituted “Subject to subparagraph (C), any information” for “Any information” in introductory provisions.

    Enacted provision · exact public law section
    (1) in subparagraph (A), by striking “Any information” and inserting “Subject to subparagraph (C), any information”; and

43. 2016

    21st Century Cures Act

    Pub. L. 114–255 § 3038(b)(2) · 130 Stat. 1033

    Added · 21 U.S.C. § 360j(h)(4)(C)

    Pub. L. 114–255, § 3038(b)(2), added subpar. (C)

    Source evidence

    Code amendment note
    Subsec. (h)(4)(C). Pub. L. 114–255, § 3038(b)(2), added subpar. (C).

    Enacted provision · exact public law section
    (2) by adding at the end the following new subparagraph: “(C) No information contained in an application for premarket approval filed with the Secretary pursuant to section 515(c) may be used to approve or clear any application submitted under section 515 or 510(k) or to classify a product under section 513(f)(2) for a combination product containing as a constituent part an approved drug (as defined in section 503(g)(5)(B)) unless— “(i) the application includes the certification or statement referenced in section 503(g)(5)(A); “(ii) the applicant provides notice as described in section 503(g)(5)(A); and “(iii) the Secretary’s approval of such application is subject to the provisions in section 503(g)(5)(C).” .

44. 2016

    21st Century Cures Act

    Pub. L. 114–255 § 3052(a)(1) · 130 Stat. 1033

    Substituted · 21 U.S.C. § 360j(m)(1)

    Pub. L. 114–255, § 3052(a)(1), substituted “not more than 8,000” for “fewer than 4,000”

    Source evidence

    Code amendment note
    Subsec. (m)(1). Pub. L. 114–255, § 3052(a)(1), substituted “not more than 8,000” for “fewer than 4,000”.

    Enacted provision · exact public law section
    (1) in paragraph (1) by striking “fewer than 4,000” and inserting “not more than 8,000”;

45. 2016

    21st Century Cures Act

    Pub. L. 114–255 § 3052(a)(2) · 130 Stat. 1033

    Substituted · 21 U.S.C. § 360j(m)(2)(A)

    Pub. L. 114–255, § 3052(a)(2), substituted “not more than 8,000” for “fewer than 4,000”

    Source evidence

    Code amendment note
    Subsec. (m)(2)(A). Pub. L. 114–255, § 3052(a)(2), substituted “not more than 8,000” for “fewer than 4,000”.

    Enacted provision · exact public law section
    (2) in paragraph (2)(A) by striking “fewer than 4,000” and inserting “not more than 8,000”; and

46. 2016

    21st Century Cures Act

    Pub. L. 114–255 § 3056(2)(C) · 130 Stat. 1033

    Struck · 21 U.S.C. § 360j(m)(4)

    Pub. L. 114–255, § 3056(2)(C), struck out “local” after “chairperson of the” in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (m)(4). Pub. L. 114–255, § 3056(2)(C), struck out “local” after “chairperson of the” in concluding provisions.

    Enacted provision · exact public law section
    (C) in the matter following subparagraph (B), by striking “local”.

47. 2016

    21st Century Cures Act

    Pub. L. 114–255 § 3056(2)(A) · 130 Stat. 1033

    1. Added · 21 U.S.C. § 360j(m)(4)(A)

       Pub. L. 114–255, § 3056(2)(A), added subpar. (A)

    2. Struck · 21 U.S.C. § 360j(m)(4)(A)

       Pub. L. 114–255, § 3056(2)(A), struck out former subpar. (A) which read as follows: “in facilities that have established, in accordance with regulations of the Secretary, a local institutional review committee to supervise clinical testing of devices in the facilities, and”

    Source evidence

    Code amendment note
    Subsec. (m)(4)(A). Pub. L. 114–255, § 3056(2)(A), added subpar. (A) and struck out former subpar. (A) which read as follows: “in facilities that have established, in accordance with regulations of the Secretary, a local institutional review committee to supervise clinical testing of devices in the facilities, and”.

    Enacted provision · exact public law section
    (A) by striking subparagraph (A) and inserting the following: “(A) in facilities in which clinical testing of devices is supervised by an institutional review committee established in accordance with the regulations of the Secretary; and” ;

48. 2016

    21st Century Cures Act

    Pub. L. 114–255 § 3056(2)(B) · 130 Stat. 1033

    Substituted · 21 U.S.C. § 360j(m)(4)(B)

    Pub. L. 114–255, § 3056(2)(B), substituted “an institutional” for “a local institutional”

    Source evidence

    Code amendment note
    Subsec. (m)(4)(B). Pub. L. 114–255, § 3056(2)(B), substituted “an institutional” for “a local institutional”.

    Enacted provision · exact public law section
    (B) in subparagraph (B), by striking “a local institutional” and inserting “an institutional”; and

49. 2016

    21st Century Cures Act

    Pub. L. 114–255 § 3052(a)(3) · 130 Stat. 1033

    Substituted · 21 U.S.C. § 360j(m)(6)(A)(ii)

    Pub. L. 114–255, § 3052(a)(3), substituted “8,000” for “4,000”

    Source evidence

    Code amendment note
    Subsec. (m)(6)(A)(ii). Pub. L. 114–255, § 3052(a)(3), substituted “8,000” for “4,000”.

    Enacted provision · exact public law section
    (3) in paragraph (6)(A)(ii), by striking “4,000” and inserting “8,000”.

50. 2016

    21st Century Cures Act

    Pub. L. 114–255 § 3060(a) · 130 Stat. 1033

    Added · 21 U.S.C. § 360j(o)

    Pub. L. 114–255, § 3060(a), added subsec. (o)

    Source evidence

    Code amendment note
    Subsec. (o). Pub. L. 114–255, § 3060(a), added subsec. (o).

    Enacted provision · exact public law section
    (a) In General.— Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amended by adding at the end the following: “(o) Regulation of Medical and Certain Decisions Support Software.— “(1) The term device, as defined in section 201(h), shall not include a software function that is intended— “(A) for administrative support of a health care facility, including the processing and maintenance of financial records, claims or billing information, appointment schedules, business analytics, information about patient populations, admissions, practice and inventory management, analysis of historical claims data to predict future utilization or cost-effectiveness, determination of health benefit eligibility, population health management, and laboratory workflow; “(B) for maintaining or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition; “(C) to serve as electronic patient records, including patient-provided information, to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart, so long as— “(i) such records were created, stored, transferred, or reviewed by health care professionals, or by individuals working under supervision of such professionals; “(ii) such records are part of health information technology that is certified under section 3001(c)(5) of the Public Health Service Act; and “(iii) such function is not intended to interpret or analyze patient records, including medical image data, for the purpose of the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition; “(D) for transferring, storing, converting formats, or displaying clinical laboratory test or other device data and results, findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings; or “(E) unless the function is intended to acquire, process, or analyze a medical image or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system, for the purpose of— “(i) displaying, analyzing, or printing medical information about a patient or other medical information (such as peer-reviewed clinical studies and clinical practice guidelines); “(ii) supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition; and “(iii) enabling such health care professional to independently review the basis for such recommendations that such software presents so that it is not the intent that such health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient. “(2) In the case of a product with multiple functions that contains— “(A) at least one software function that meets the criteria under paragraph (1) or that otherwise does not meet the definition of device under section 201(h); and “(B) at least one function that does not meet the criteria under paragraph (1) and that otherwise meets the definition of a device under section 201(h), the Secretary shall not regulate the software function of such product described in subparagraph (A) as a device. Notwithstanding the preceding sentence, when assessing the safety and effectiveness of the device function or functions of such product described in subparagraph (B), the Secretary may assess the impact that the software function or functions described in subparagraph (A) have on such device function or functions. “(3) (A) Notwithstanding paragraph (1), a software function described in subparagraph (C), (D), or (E) of paragraph (1) shall not be excluded from the definition of device under section 201(h) if— “(i) the Secretary makes a finding that use of such software function would be reasonably likely to have serious adverse health consequences; and “(ii) the software function has been identified in a final order issued by the Secretary under subparagraph (B). “(B) Subparagraph (A) shall apply only if the Secretary— “(i) publishes a notification and proposed order in the Federal Register; “(ii) includes in such notification the Secretary’s finding, including the rationale and identification of the evidence on which such finding was based, as described in subparagraph (A)(i); and “(iii) provides for a period of not less than 30 calendar days for public comment before issuing a final order or withdrawing such proposed order. “(C) In making a finding under subparagraph (A)(i) with respect to a software function, the Secretary shall consider— “(i) the likelihood and severity of patient harm if the software function were to not perform as intended; “(ii) the extent to which the software function is intended to support the clinical judgment of a health care professional; “(iii) whether there is a reasonable opportunity for a health care professional to review the basis of the information or treatment recommendation provided by the software function; and “(iv) the intended user and user environment, such as whether a health care professional will use a software function of a type described in subparagraph (E) of paragraph (1). “(4) Nothing in this subsection shall be construed as limiting the authority of the Secretary to— “(A) exercise enforcement discretion as to any device subject to regulation under this Act; “(B) regulate software used in the manufacture and transfusion of blood and blood components to assist in the prevention of disease in humans; or “(C) regulate software as a device under this Act if such software meets the criteria under section 513(a)(1)(C).” .

51. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 502(b)(1)(B) · 131 Stat. 1005

    Inserted · 21 U.S.C. § 360j(m)(4)

    Pub. L. 115–52, § 502(b)(1)(B), inserted “or an appropriate local committee” after “review committee” in two places in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (m)(4). Pub. L. 115–52, § 502(b)(1)(B), inserted “or an appropriate local committee” after “review committee” in two places in concluding provisions.

    Enacted provision · exact public law section
    (B) in the matter following subparagraph (B), by inserting “or an appropriate local committee” after “review committee” each place such term appears; and

52. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 502(b)(1)(A) · 131 Stat. 1005

    Inserted · 21 U.S.C. § 360j(m)(4)(B)

    Pub. L. 115–52, § 502(b)(1)(A), inserted “or an appropriate local committee” after “review committee” in two places

    Source evidence

    Code amendment note
    Subsec. (m)(4)(B). Pub. L. 115–52, § 502(b)(1)(A), inserted “or an appropriate local committee” after “review committee” in two places.

    Enacted provision · exact public law section
    (A) in subparagraph (B), by inserting “or an appropriate local committee” after “review committee” each place such term appears; and

53. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 502(b)(2) · 131 Stat. 1005

    Substituted · 21 U.S.C. § 360j(m)(6)(A)(iv)

    Pub. L. 115–52, § 502(b)(2), substituted “2022” for “2017”

    Source evidence

    Code amendment note
    Subsec. (m)(6)(A)(iv). Pub. L. 115–52, § 502(b)(2), substituted “2022” for “2017”.

    Enacted provision · exact public law section
    (2) in paragraph (6)(A)(iv), by striking “2017” and inserting “2022”.

54. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 706(a) · 131 Stat. 1005

    Added · 21 U.S.C. § 360j(p)

    Pub. L. 115–52, § 706(a), added subsec. (p)

    Source evidence

    Code amendment note
    Subsec. (p). Pub. L. 115–52, § 706(a), added subsec. (p).

    Enacted provision · exact public law section
    (a) Approval of Applications for Certain Diagnostic Medical Imaging Devices.— Section 520 of the Federal Food, Drug, and Cosmetic Act (42 U.S.C. 360j) is amended by adding at the end the following: “(p) Diagnostic Imaging Devices Intended for Use With Contrast Agents.— “(1) In general.— The Secretary may, subject to the succeeding provisions of this subsection, approve an application (or a supplement to such an application) submitted under section 515 with respect to an applicable medical imaging device, or, in the case of an applicable medical imaging device for which a notification is submitted under section 510(k), may make a substantial equivalence determination with respect to an applicable medical imaging device, or may grant a request submitted under section 513(f)(2) for an applicable medical imaging device, if such application, notification, or request involves the use of a contrast agent that is not— “(A) in a concentration, rate of administration, or route of administration that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines that such differences in concentration, rate of administration, or route of administration exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device; “(B) in a region, organ, or system of the body that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines that such differences in region, organ, or system of the body exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device; “(C) in a patient population that is different from those described in the approved labeling of the contrast agent, except that the Secretary may approve such application, make such substantial equivalence determination, or grant such request if the Secretary determines such differences in patient population exist but do not adversely affect the safety and effectiveness of the contrast agent when used with the device; or “(D) in an imaging modality that is different from those described in the approved labeling of the contrast agent. “(2) Premarket review.— The agency center charged with premarket review of devices shall have primary jurisdiction with respect to the review of an application, notification, or request described in paragraph (1). In conducting such review, such agency center may— “(A) consult with the agency center charged with the premarket review of drugs or biological products; and “(B) review information and data provided to the Secretary by the sponsor of a contrast agent in an application submitted under section 505 of this Act or section 351 of the Public Health Service Act, so long as the sponsor of such contrast agent has provided to the sponsor of the applicable medical imaging device that is the subject of such review a right of reference and the application is submitted in accordance with this subsection. “(3) Applicable requirements.— An application submitted under section 515, a notification submitted under section 510(k), or a request submitted under section 513(f)(2), as described in paragraph (1), with respect to an applicable medical imaging device shall be subject to the requirements of such respective section. Such application, notification, or request shall only be subject to the requirements of this Act applicable to devices. “(4) Definitions.— For purposes of this subsection— “(A) the term ‘applicable medical imaging device’ means a device intended to be used in conjunction with a contrast agent (or class of contrast agents) for an imaging use that is not described in the approved labeling of such contrast agent (or the approved labeling of any contrast agent in the same class as such contrast agent); and “(B) the term ‘contrast agent’ means a drug that is approved under section 505 or licensed under section 351 of the Public Health Service Act, is intended for use in conjunction with an applicable medical imaging device, and— “(i) is a diagnostic radiopharmaceutical, as defined in section 315.2 and 601.31 of title 21, Code of Federal Regulations (or any successor regulations); or “(ii) is a diagnostic agent that improves the visualization of structure or function within the body by increasing the relative difference in signal intensity within the target tissue, structure, or fluid.” .

55. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 709(a) · 131 Stat. 1005

    Added · 21 U.S.C. § 360j(q)

    Pub. L. 115–52, § 709(a), added subsec. (q). Amendment was executed to this section as amended by section 706(a) of Pub. L. 115–52, notwithstanding directory language referring to section as amended by section 708 of Pub. L. 115–52, which did not amend this section

    Source evidence

    Code amendment note
    Subsec. (q). Pub. L. 115–52, § 709(a), added subsec. (q). Amendment was executed to this section as amended by section 706(a) of Pub. L. 115–52, notwithstanding directory language referring to section as amended by section 708 of Pub. L. 115–52, which did not amend this section.

    Enacted provision · exact public law section
    (a) In General.— Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j), as amended by section 708, is further amended by adding at the end the following: “(q) Regulation of Over-the-Counter Hearing Aids.— “(1) Definition.— “(A) In general.— In this subsection, the term ‘over-the-counter hearing aid’ means a device that— “(i) uses the same fundamental scientific technology as air conduction hearing aids (as defined in section 874.3300 of title 21, Code of Federal Regulations) (or any successor regulation) or wireless air conduction hearing aids (as defined in section 874.3305 of title 21, Code of Federal Regulations) (or any successor regulation); “(ii) is intended to be used by adults age 18 and older to compensate for perceived mild to moderate hearing impairment; “(iii) through tools, tests, or software, allows the user to control the over-the-counter hearing aid and customize it to the user’s hearing needs; “(iv) may— “(I) use wireless technology; or “(II) include tests for self-assessment of hearing loss; and “(v) is available over-the-counter, without the supervision, prescription, or other order, involvement, or intervention of a licensed person, to consumers through in-person transactions, by mail, or online. “(B) Exception.— Such term does not include a personal sound amplification product intended to amplify sound for nonhearing impaired consumers in situations including hunting and bird-watching. “(2) Regulation.— An over-the-counter hearing aid shall be subject to the regulations promulgated in accordance with section 709(b) of the FDA Reauthorization Act of 2017 and shall be exempt from sections 801.420 and 801.421 of title 21, Code of Federal Regulations (or any successor regulations).” .

56. 2022

    FDA User Fee Reauthorization Act of 2022

    Pub. L. 117–180 div. F title V § 5002 · 136 Stat. 2114

    Substituted · 21 U.S.C. § 360j(m)(6)(A)(iv)

    Pub. L. 117–180 substituted “December 17” for “October 1”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 117–180 substituted “December 17” for “October 1”.

    Enacted provision · exact public law section
    SEC. 5002. REAUTHORIZATION OF THE HUMANITARIAN DEVICE EXEMPTION INCENTIVE.   Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking “October 1” and inserting “December 17”.

57. 2022

    Further Continuing Appropriations and Extensions Act, 2023

    Pub. L. 117–229 div. C title III § 303 · 136 Stat. 2308

    Substituted · 21 U.S.C. § 360j(m)(6)(A)(iv)

    Pub. L. 117–229 substituted “December 24, 2022” for “December 17, 2022”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 117–229 substituted “December 24, 2022” for “December 17, 2022”.

    Enacted provision · exact public law section
    SEC. 303. REAUTHORIZATION OF THE HUMANITARIAN DEVICE EXEMPTION INCENTIVE.   Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking “December 17, 2022” and inserting “December 24, 2022”.

58. 2022

    Pub. L. 117–286 § 4(a)(156) · 136 Stat. 4196

    Substituted · 21 U.S.C. § 360j(f)(3)

    Pub. L. 117–286 substituted “Section 1013 of title 5” for “Section 14 of the Federal Advisory Committee Act” in concluding provisions

    Source evidence

    Code amendment note
    Subsec. (f)(3). Pub. L. 117–286 substituted “Section 1013 of title 5” for “Section 14 of the Federal Advisory Committee Act” in concluding provisions.

    Enacted provision · exact public law section
    (156) Section 520(f)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(f)(3)) is amended (matter at end) by striking “Section 14 of the Federal Advisory Committee Act” and inserting “Section 1013 of title 5, United States Code,”.

59. 2022

    Food and Drug Omnibus Reform Act of 2022

    Pub. L. 117–328 § 3601(b) · 136 Stat. 4459

    Added · 21 U.S.C. § 360j(g)(9)

    Pub. L. 117–328, § 3601(b), added par. (9)

    Source evidence

    Code amendment note
    Subsec. (g)(9). Pub. L. 117–328, § 3601(b), added par. (9).

    Enacted provision · exact public law section
    (b) Devices.— Section 520(g) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)) is amended by adding at the end the following: “(9) (A) (i) The sponsor of a device for which submission of an application for an investigational device exemption is required shall submit to the Secretary in such application a diversity action plan for clinical studies of the device, in the form and manner specified in guidance issued by the Secretary. “(ii) The sponsor of a device for which submission of an application for an investigational device exemption is not required, except for a device being studied as described in section 812.2(c) of title 21, Code of Federal Regulations (or successor regulations), shall develop a diversity action plan for any clinical study with respect to the device. Such diversity action plan shall be submitted to the Secretary in any premarket notification under section 510(k), request for classification under section 513(f)(2), or application for premarket approval under section 515 for such device. “(B) A diversity action plan under clause (i) or (ii) of subparagraph (A) shall include— “(i) the sponsor’s goals for enrollment in the clinical study; “(ii) the sponsor’s rationale for such goals; and “(iii) an explanation of how the sponsor intends to meet such goals. “(C) (i) On the initiative of the Secretary or at the request of a sponsor, the Secretary may waive any requirement in subparagraph (A) or (B) if the Secretary determines that a waiver is necessary based on what is known or can be determined about the prevalence or incidence of the disease or condition for which the device is under investigation (including in terms of the patient population that may use the device), if conducting a clinical investigation in accordance with a diversity action plan would otherwise be impracticable, or if such waiver is necessary to protect public health during a public health emergency. “(ii) The Secretary shall issue a written response granting or denying a request from a sponsor for a waiver within 60 days of receiving such request. “(D) No diversity action plan shall be required for a submission described in section 561.” .

    Effective date note
    Subsec. (g)(9) of this section, as added by section 3601(b) of Pub. L. 117–328, applicable only with respect to clinical investigations for which enrollment commences after the date that is 180 days after the publication of final guidance required under section 3602 of Pub. L. 117–328, see section 3602(c) of Pub. L. 117–328, set out as a note under section 355 of this title.

60. 2022

    Food and Drug Omnibus Reform Act of 2022

    Pub. L. 117–328 § 3103 · 136 Stat. 4459

    Substituted · 21 U.S.C. § 360j(m)(6)(A)(iv)

    Pub. L. 117–328, § 3103, substituted “October 1, 2027” for “December 24, 2022”

    Source evidence

    Code amendment note
    Subsec. (m)(6)(A)(iv). Pub. L. 117–328, § 3103, substituted “October 1, 2027” for “December 24, 2022”.

    Enacted provision · exact public law section
    SEC. 3103. REAUTHORIZATION OF THE HUMANITARIAN DEVICE EXEMPTION INCENTIVE.   Section 520(m)(6)(A)(iv) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(m)(6)(A)(iv)) is amended by striking “December 24, 2022” and inserting “October 1, 2027”.

    Effective date note
    Subsec. (g)(9) of this section, as added by section 3601(b) of Pub. L. 117–328, applicable only with respect to clinical investigations for which enrollment commences after the date that is 180 days after the publication of final guidance required under section 3602 of Pub. L. 117–328, see section 3602(c) of Pub. L. 117–328, set out as a note under section 355 of this title.

68 of 68 references resolved to an enrolled provision