§ 360l. Postmarket surveillance

Footnotes

1. 1 So in original. Probably should be “this”.

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

   Pub. L. 101–629 § 10 · 104 Stat. 4469

   Enacted · 21 U.S.C. § 360l

   June 25, 1938, ch. 675, § 522, as added Pub. L. 101–629, § 10, Nov. 28, 1990, 104 Stat. 4521

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 522, as added Pub. L. 101–629, § 10, Nov. 28, 1990, 104 Stat. 4521

   Enacted provision · exact public law section
   SEC. 10. POSTMARKET SURVEILLANCE. Subchapter A of chapter 5 is amended by inserting after section 521 (21 U.S.C. 360k) the following new section: “Sec. 522. “postmarket surveillance (a) In General.— “(1) Required surveillance.— The Secretary shall require a manufacturer to conduct postmarket surveillance for any device of the manufacturer first introduced or delivered for introduction into interstate commerce after January 1, 1991, that— “(A) is a permanent implant the failure of which may cause serious, adverse health consequences or death, “(B) is intended for a use in supporting or sustaining human life, or “(C) potentially presents a serious risk to human health. “(2) Discretionary surveillance.— The Secretary may re-quire a manufacturer to conduct postmarket surveillance for a device of the manufacturer if the Secretary determines that postmarket surveillance of the device is necessary to protect the public health or to provide safety or effectiveness data for the device. “(b) Surveillance Approval.— Each manufacturer required to conduct a surveillance of a device under subsection (a) shall, within 30 days of the first introduction or delivery for introduction of such device into interstate commerce submit, for the approval of the Secretary, a protocol for the required surveillance. The Secretary, within 60 days of the receipt of such protocol, shall determine if the principal investigator proposed to be used in the surveillance has sufficient qualifications and experience to conduct such surveillance and if such protocol will result in collection of useful data or other information necessary to protect the public health and to provide safety and effectiveness information for the device. The Secretary may not approve such a protocol until it has been reviewed by an appropriately Qualified scientific and technical review committee established by the Secretary.”.

2. 1992

   Medical Device Amendments of 1992

   Pub. L. 102–300 § 3(b) · 106 Stat. 238

   1. Substituted · 21 U.S.C. § 360l(b)

      Pub. L. 102–300 substituted “(a)(1)” for “(a)”

   2. Inserted · 21 U.S.C. § 360l(b)

      Pub. L. 102–300 inserted comma after “commerce”

   3. Inserted · 21 U.S.C. § 360l(b)

      Pub. L. 102–300 inserted after first sentence “Each manufacturer required to conduct a surveillance of a device under subsection (a)(2) of this section shall, within 30 days after receiving notice that the manufacturer is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveillance.”

   Source evidence

   Code amendment note
   Subsec. (b). Pub. L. 102–300 substituted “(a)(1)” for “(a)”, inserted comma after “commerce”, and inserted after first sentence “Each manufacturer required to conduct a surveillance of a device under subsection (a)(2) of this section shall, within 30 days after receiving notice that the manufacturer is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveillance.”

   Enacted provision · exact public law section
   (b) Approval.— Section 522(b) (21 U.S.C. 3601(b)) is amended— (1) by striking out “(a)” and inserting in lieu thereof “(a)(1)”; (2) by inserting a comma after “commerce”; and (3) by adding after the first sentence the following: “Each manufacturer required to conduct a surveillance of a device under subsection (a)(2) shall, within 30 days after receiving notice that the manufacturer is required to conduct such surveillance, submit, for the approval of the Secretary, a protocol for the required surveillance.”.

3. 1997

   Food and Drug Administration Modernization Act of 1997

   Pub. L. 105–115 title II § 212 · 111 Stat. 2296

   1. Amended · 21 U.S.C. § 360l

      Pub. L. 105–115 amended section generally

   2. Substituted · 21 U.S.C. § 360l

      Pub. L. 105–115 substituting present provisions for former provisions which related to required surveillance, discretionary surveillance, and surveillance approval

   Source evidence

   Code amendment note
   Pub. L. 105–115 amended section generally, substituting present provisions for former provisions which related to required surveillance, discretionary surveillance, and surveillance approval.

   Enacted provision · exact public law section
   SEC. 212. POSTMARKET SURVEILLANCE. Effective 90 days after the date of the enactment of this Act, section 522 (21 U.S.C. 3601) is amended to read as follows: “Sec. 522. “POSTMARKET SURVEILLANCE (a) In General.— The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer which is a class II or class III device the failure of which would be reasonably likely to have serious adverse health consequences or which is intended to be— “(1) implanted in the human body for more than one year, or “(2) a life sustaining or life supporting device used outside a device user facility. “(b) Surveillance Approval.— Each manufacturer required to conduct a surveillance of a device shall, within 30 days of receiving an order from the Secretary prescribing that the manufacturer is required under this section to conduct such surveillance, submit, for the approval of the Secretary, a plan for the required surveillance. The Secretary, within 60 days of the receipt of such plan, shall determine if the person designated to conduct the surveillance has appropriate qualifications and experience to undertake such surveillance and if the plan will result in the collection of useful data that can reveal unforeseen adverse events or other information necessary to protect the public health. The Secretary, in consultation with the manufacturer, may by order require a prospective surveillance period of up to 36 months. Any determination by the Secretary that a longer period is necessary shall be made by mutual agreement between the Secretary and the manufacturer or, if no agreement can be reached, after the completion of a dispute resolution process as described in section 562.”.

   Effective date note
   Pub. L. 105–115, title II, § 212, Nov. 21, 1997, 111 Stat. 2346, provided in part that the amendment made by that section is effective 90 days after Nov. 21, 1997.

4. 2007

   Pediatric Medical Device Safety and Improvement Act of 2007

   Pub. L. 110–85 § 307(1) · 121 Stat. 823

   Changed · 21 U.S.C. § 360l

   Pub. L. 110–85, § 307(1), made technical amendment to section catchline

   Source evidence

   Code amendment note
   Pub. L. 110–85, § 307(1), made technical amendment to section catchline.

   Enacted provision · exact public law section
   (1) by amending the section heading and designation to read as follows: “SEC. 522. POSTMARKET SURVEILLANCE.” ;

5. 2007

   Pediatric Medical Device Safety and Improvement Act of 2007

   Pub. L. 110–85 § 307(2) · 121 Stat. 823

   1. Added · 21 U.S.C. § 360l(a)

      Pub. L. 110–85, § 307(2), added subsec. (a)

   2. Struck · 21 U.S.C. § 360l(a)

      Pub. L. 110–85, § 307(2), struck out former subsec. (a). Prior to amendment, text read as follows: “The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer which is a class II or class III device the failure of which would be reasonably likely to have serious adverse health consequences or which is intended to be—

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 110–85, § 307(2), added subsec. (a) and struck out former subsec. (a). Prior to amendment, text read as follows: “The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer which is a class II or class III device the failure of which would be reasonably likely to have serious adverse health consequences or which is intended to be—

   “(1) implanted in the human body for more than one year, or “(2) a life sustaining or life supporting device used outside a device user facility.”

   Enacted provision · exact public law section
   (2) by striking subsection (a) and inserting the following: “(a) Postmarket Surveillance.— “(1) In general.— “(A) Conduct.— The Secretary may by order require a manufacturer to conduct postmarket surveillance for any device of the manufacturer that is a class II or class III device— “(i) the failure of which would be reasonably likely to have serious adverse health consequences; “(ii) that is expected to have significant use in pediatric populations; or “(iii) that is intended to be— “(I) implanted in the human body for more than 1 year; or “(II) a life-sustaining or life-supporting device used outside a device user facility. “(B) Condition.— The Secretary may order a postmarket surveillance under subparagraph (A) as a condition to approval or clearance of a device described in subparagraph (A)(ii). “(2) Rule of construction.— The provisions of paragraph (1) shall have no effect on authorities otherwise provided under the Act or regulations issued under this Act.” ; and

6. 2007

   Pediatric Medical Device Safety and Improvement Act of 2007

   Pub. L. 110–85 § 307(3) · 121 Stat. 823

   1. Amended · 21 U.S.C. § 360l(b)

      Pub. L. 110–85, § 307(3), designated existing provisions as par. (1)

   2. Inserted · 21 U.S.C. § 360l(b)

      Pub. L. 110–85, § 307(3), inserted par. heading

   3. Substituted · 21 U.S.C. § 360l(b)

      Pub. L. 110–85, § 307(3), substituted “Except as provided in paragraph (2), the Secretary, in consultation” for “The Secretary, in consultation”

   4. Substituted · 21 U.S.C. § 360l(b)

      Pub. L. 110–85, § 307(3), substituted “Except as provided in paragraph (2), any determination” for “Any determination”

   5. Added · 21 U.S.C. § 360l(b)

      Pub. L. 110–85, § 307(3), added par. (2)

   Source evidence

   Code amendment note
   Subsec. (b). Pub. L. 110–85, § 307(3), designated existing provisions as par. (1), inserted par. heading, substituted “Except as provided in paragraph (2), the Secretary, in consultation” for “The Secretary, in consultation” and “Except as provided in paragraph (2), any determination” for “Any determination”, and added par. (2).

   Enacted provision · exact public law section
   (3) in subsection (b)— (A) by striking “(b) Surveillance Approval.—Each” and inserting the following: “(b) Surveillance Approval.— “(1) In general.— Each” ; (B) by striking “The Secretary, in consultation” and inserting “Except as provided in paragraph (2), the Secretary, in consultation”; (C) by striking “Any determination” and inserting “Except as provided in paragraph (2), any determination”; and (D) by adding at the end the following: “(2) Longer surveillance for pediatric devices.— The Secretary may by order require a prospective surveillance period of more than 36 months with respect to a device that is expected to have significant use in pediatric populations if such period of more than 36 months is necessary in order to assess the impact of the device on growth and development, or the effects of growth, development, activity level, or other factors on the safety or efficacy of the device. “(c) Dispute Resolution.— A manufacturer may request review under section 562 of any order or condition requiring postmarket surveillance under this section. During the pendency of such review, the device subject to such a postmarket surveillance order or condition shall not, because of noncompliance with such order or condition, be deemed in violation of section 301(q)(1)(C), adulterated under section 501(f)(1), misbranded under section 502(t)(3), or in violation of, as applicable, section 510(k) or section 515, unless deemed necessary to protect the public health.” .

7. 2007

   Pediatric Medical Device Safety and Improvement Act of 2007

   Pub. L. 110–85 § 307(3)(D) · 121 Stat. 823

   Added · 21 U.S.C. § 360l(c)

   Pub. L. 110–85, § 307(3)(D), added subsec. (c)

   Source evidence

   Code amendment note
   Subsec. (c). Pub. L. 110–85, § 307(3)(D), added subsec. (c).

   Enacted provision · exact public law section
   (D) by adding at the end the following: “(2) Longer surveillance for pediatric devices.— The Secretary may by order require a prospective surveillance period of more than 36 months with respect to a device that is expected to have significant use in pediatric populations if such period of more than 36 months is necessary in order to assess the impact of the device on growth and development, or the effects of growth, development, activity level, or other factors on the safety or efficacy of the device. “(c) Dispute Resolution.— A manufacturer may request review under section 562 of any order or condition requiring postmarket surveillance under this section. During the pendency of such review, the device subject to such a postmarket surveillance order or condition shall not, because of noncompliance with such order or condition, be deemed in violation of section 301(q)(1)(C), adulterated under section 501(f)(1), misbranded under section 502(t)(3), or in violation of, as applicable, section 510(k) or section 515, unless deemed necessary to protect the public health.” .

8. 2012

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 § 616(1) · 126 Stat. 993

   Inserted · 21 U.S.C. § 360l(a)(1)(A)

   Pub. L. 112–144, § 616(1), inserted “, at the time of approval or clearance of a device or at any time thereafter,” after “by order” in introductory provisions

   Source evidence

   Code amendment note
   Subsec. (a)(1)(A). Pub. L. 112–144, § 616(1), inserted “, at the time of approval or clearance of a device or at any time thereafter,” after “by order” in introductory provisions.

   Enacted provision · exact public law section
   (1) in subsection (a)(1)(A), in the matter preceding clause (i), by inserting “, at the time of approval or clearance of a device or at any time thereafter,” after “by order”; and

9. 2012

   Food and Drug Administration Safety and Innovation Act

   Pub. L. 112–144 § 616(2) · 126 Stat. 993

   Inserted · 21 U.S.C. § 360l(b)(1)

   Pub. L. 112–144, § 616(2), inserted “The manufacturer shall commence surveillance under this section not later than 15 months after the day on which the Secretary issues an order under this section.” after “the public health.”

   Source evidence

   Code amendment note
   Subsec. (b)(1). Pub. L. 112–144, § 616(2), inserted “The manufacturer shall commence surveillance under this section not later than 15 months after the day on which the Secretary issues an order under this section.” after “the public health.”

   Enacted provision · exact public law section
   (2) Deadline. in subsection (b)(1), by inserting “The manufacturer shall commence surveillance under this section not later than 15 months after the day on which the Secretary issues an order under this section.” after the second sentence.

17 of 17 references resolved to an enrolled provision