§ 374. Inspection

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. 75–675 § 704 · 52 Stat. 1040

   Enacted · 21 U.S.C. § 374

   June 25, 1938, ch. 675, § 704, 52 Stat. 1057

   Source evidence

   Code source credit
   June 25, 1938, ch. 675, § 704, 52 Stat. 1057

   Enacted provision · exact public law section
   Sec. 704. factory inspection For purposes of enforcement of this Act, officers or Factory inspection. employees duly designated by the Secretary, after first making request and obtaining permission of the owner, operator, or custodian thereof, are authorized (1) to enter, at reasonable times, any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or are held after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in interstate commerce; and (2) to inspect, at reasonable times, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials, containers, and labeling therein.

2. 1962

   Drug Amendments of 1962

   Pub. L. 87–781 § 201(a) · 76 Stat. 780

   Struck · 21 U.S.C. § 374(a)

   Pub. L. 87–781, § 201(a), extended the inspection, where prescription drugs are manufactured, processed, packed, or held, to all things bearing on whether adulterated or misbranded drugs, or any which may not be manufactured, introduced in interstate commerce, or sold or offered for sale under any provision of this chapter, have been or are being manufactured, processed, packed, transported or held in any such place, or otherwise bearing on violation of this chapter, but excluded from such inspection, data concerning finance, sales other than shipment, pricing, personnel other than qualifications of technical and professional personnel, research other than relating to new drugs subject to reporting, provided that provisions of second sentence of this subsection shall be inapplicable to pharmacies, practitioners and other persons enumerated in pars. (1) to (4), and struck out “are held” before “after such introduction”

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 87–781, § 201(a), extended the inspection, where prescription drugs are manufactured, processed, packed, or held, to all things bearing on whether adulterated or misbranded drugs, or any which may not be manufactured, introduced in interstate commerce, or sold or offered for sale under any provision of this chapter, have been or are being manufactured, processed, packed, transported or held in any such place, or otherwise bearing on violation of this chapter, but excluded from such inspection, data concerning finance, sales other than shipment, pricing, personnel other than qualifications of technical and professional personnel, research other than relating to new drugs subject to reporting, provided that provisions of second sentence of this subsection shall be inapplicable to pharmacies, practitioners and other persons enumerated in pars. (1) to (4), and struck out “are held” before “after such introduction”.

   Enacted provision · exact public law section
   (a) Section 704(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended to read as follows: “(a) For purposes of enforcement of this Act, officers or employees duly designated by the Secretary, upon presenting appropriate credentials and a written notice to the owner, operator, or agent in charge, are authorized (1) to enter, at reasonable times? any factory, warehouse, or establishment in which food, drugs, devices, or cosmetics are manufactured, processed, packed, or held, for introduction into interstate commerce or after such introduction, or to enter any vehicle being used to transport or hold such food, drugs, devices, or cosmetics in interstate commerce; and (2) to inspect, at reasonable times and within reasonable limits and in a reasonable manner, such factory, warehouse, establishment, or vehicle and all pertinent equipment, finished and unfinished materials; containers, and labeling therein. In the case of any factory, warehouse, establishment, or consulting laboratory in which prescription drugs are manufactured, processed, packed, or held, the inspection shall extend to all things therein, (including records, files, papers, processes, controls, and facilities) bearing on whether prescription drugs which are adulterated or misbranded within the meaning of this Act, or which may not be manufactured, introduced into interstate commerce, or sold, or offered for sale by reason of any provision of this Act, have been or are being manufactured, processed, packed, transported, or held in any such place, or otherwise bearing on violation of this Act. No inspection authorized for prescription drugs by the preceding sentence shall extend to (A) financial data, (B) sales data other than shipment data, (C) pricing data, (D) personnel data (other than data as to qualifications of technical and professional personnel performing functions subject to this Act), and (E) research data (other than data, relating to new drugs and antibiotic drugs, subject to reporting and inspection under regulations lawfully issued pursuant to section 505 (i) or (j) or section 507 (d) or (g) of this Act, and data, relating Ante, pp. 783, 782, 787. to other drugs, which in the case of a new drug would be subject to reporting or inspection under lawful regulations issued pursuant to section 505(j) of this Act). A separate notice shall be given for each such inspection, but a notice shall not be required for each entry made during the period covered by the inspection. Each such inspection shall be commenced and completed with reasonable promptness. The provisions of the second sentence of this subsection shall not apply to— “(1) pharmacies which maintain establishments in conformance with any applicable local laws regulating the practice of pharmacy and medicine and which are regularly engaged in dispensing prescription drugs, upon prescriptions of practitioners licensed to administer such drugs to patients under the care of such practitioners in the course of their professional practice, and which do not, either through a subsidiary or otherwise, manufacture, prepare, propagate, compound, or process drugs for sale other than in the regular course of their business of dispensing or selling drugs at retail; “(2) practitioners licensed by law to prescribe or administer drugs and who manufacture, prepare, propagate, compound, or process drugs solely for use in the course of their professional practice; “(3) persons who manufacture, prepare, propagate, compound, or process drugs solely for use in research, teaching, or chemical analysis and not for sale; “(4) such other classes of persons as the Secretary may by regulation exempt from the application of this section upon a finding that inspection as applied to such classes of persons in accordance with this section is not necessary for the protection of the public health.”

3. 1962

   Drug Amendments of 1962

   Pub. L. 87–781 § 201(b) · 76 Stat. 780

   Inserted · 21 U.S.C. § 374(b)

   Pub. L. 87–781, § 201(b), inserted “consulting laboratory” after “warehouse”

   Source evidence

   Code amendment note
   Subsec. (b). Pub. L. 87–781, § 201(b), inserted “consulting laboratory” after “warehouse”.

   Enacted provision · exact public law section
   (b) Section 704(b) of such Act (21 U.S.C. 374(b)) is amended by 67 Stat. 477. inserting after “warehouse,” the words “consulting laboratory,”.

4. 1976

   Medical Device Amendments of 1976

   Pub. L. 94–295 § 6(a) · 90 Stat. 539

   Inserted · 21 U.S.C. § 374(a)

   Pub. L. 94–295, § 6(a)–(c), expanded existing provisions to encompass medical devices by inserting references to factories, warehouses, establishments, and consulting laboratories in which restricted devices are manufactured, processed, packed, or held, inspections relating to devices, reporting and inspection regulations issued pursuant to sections 360i and 360j(g) of this title, and the manufacture and processing of devices

   Source evidence

   Code amendment note
   Subsec. (a). Pub. L. 94–295, § 6(a)–(c), expanded existing provisions to encompass medical devices by inserting references to factories, warehouses, establishments, and consulting laboratories in which restricted devices are manufactured, processed, packed, or held, inspections relating to devices, reporting and inspection regulations issued pursuant to sections 360i and 360j(g) of this title, and the manufacture and processing of devices.

   Enacted provision · exact public law section
   (a) The second sentence of subsection (a) of section 704 (21 U.S.C. 374) is amended by inserting “or restricted devices” after “prescription drugs” both times it appears.

5. 1976

   Medical Device Amendments of 1976

   Pub. L. 94–295 § 6(d) · 90 Stat. 539

   Added · 21 U.S.C. § 374(e)

   Pub. L. 94–295, § 6(d), added subsec. (e)

   Source evidence

   Code amendment note
   Subsec. (e). Pub. L. 94–295, § 6(d), added subsec. (e).

   Enacted provision · exact public law section
   (d) Section 704 is amended by adding at the end the following new subsection: “(e) Every person required, under section 519 or 520(g) to maintain Records, accessibility. records and every person who is in charge or custody of such records shall, upon request of an officer or employee designated by the Secretary, permit such officer or employee at all reasonable times to have access to, and to copy and verify, such records.”.

6. 1980

   Infant Formula Act of 1980

   Pub. L. 96–359 § 4(1) · 94 Stat. 1190

   1. Inserted · 21 U.S.C. § 374(a)(1)

      Pub. L. 96–359, § 4(1), (2), restructured first five sentences of former subsec. (a) as par. (1) and, as so restructured, inserted reference to paragraph (3)

   2. Substituted · 21 U.S.C. § 374(a)(1)

      Pub. L. 96–359, § 4(1), (2), restructured first five sentences of former subsec. (a) as par. (1) and, as so restructured, substituted “(A)” and “(B)” for “(1)” and “(2)”, respectively

   Source evidence

   Code amendment note
   Subsec. (a)(1). Pub. L. 96–359, § 4(1), (2), restructured first five sentences of former subsec. (a) as par. (1) and, as so restructured, inserted reference to paragraph (3) and substituted “(A)” and “(B)” for “(1)” and “(2)”, respectively.

   Enacted provision · exact public law section
   (1) in the first sentence, by inserting “(1)” before “For purposes” and by redesignating clauses (1) and (2) as clauses (A) and (B), respectively;

7. 1980

   Infant Formula Act of 1980

   Pub. L. 96–359 § 4(3) · 94 Stat. 1190

   1. Redesignated · 21 U.S.C. § 374(a)(2)

      Pub. L. 96–359, § 4(3), redesignated sixth sentence of former subsec. (a) as par. (2) and, as so redesignated

   2. Substituted · 21 U.S.C. § 374(a)(2)

      Pub. L. 96–359, § 4(3), substituted reference to second sentence of paragraph (1) for reference to former second sentence of this subsection, and “(A)”, “(B)”, “(C)”, and “(D)”, for “(1)”, “(2)”, “(3)”, and “(4)”, respectively

   Source evidence

   Code amendment note
   Subsec. (a)(2). Pub. L. 96–359, § 4(3), redesignated sixth sentence of former subsec. (a) as par. (2) and, as so redesignated, substituted reference to second sentence of paragraph (1) for reference to former second sentence of this subsection, and “(A)”, “(B)”, “(C)”, and “(D)”, for “(1)”, “(2)”, “(3)”, and “(4)”, respectively.

   Enacted provision · exact public law section
   (3) in the sixth sentence, (A) by striking out “The provisions of the second sentence of this subsection” and inserting in lieu thereof the following: “(2) The provisions of the second sentence of paragraph (1)”, and (B) by redesignating paragraphs (1) through (4) as subparagraphs (A) through (D), respectively; and

8. 1980

   Infant Formula Act of 1980

   Pub. L. 96–359 § 4(4) · 94 Stat. 1190

   Added · 21 U.S.C. § 374(a)(3)

   Pub. L. 96–359, § 4(4), added par. (3)

   Source evidence

   Code amendment note
   Subsec. (a)(3). Pub. L. 96–359, § 4(4), added par. (3).

   Enacted provision · exact public law section
   (4) by adding at the end the following: “(3) An officer or employee making an inspection under paragraph (1) for purposes of enforcing the requirements of section 412 applicable Ante, p. 1190. to infant formulas shall be permitted, at all reasonable times, to have access to and to copy and verify any records— “(A) bearing on whether the infant formula manufactured or held in the facility inspected meets the requirements of section 412, or “(B) required to be maintained under section 412.”.

9. 1993

   Nutrition Labeling and Education Act Amendments of 1993

   Pub. L. 103–80 § 3(aa) · 107 Stat. 773

   Substituted · 21 U.S.C. § 374(a)(1)

   Pub. L. 103–80 substituted a comma for semicolon after “finished and unfinished materials” and “section 355(i) or (k)” for “section 355(i) or (j)”

   Source evidence

   Code amendment note
   Subsec. (a)(1). Pub. L. 103–80 substituted a comma for semicolon after “finished and unfinished materials” and “section 355(i) or (k)” for “section 355(i) or (j)”.

   Enacted provision · exact public law section
   SEC. 3. TECHNICAL AMENDMENTS TO FEDERAL FOOD, DRUG, AND COSMETIC ACT. (a) Reference.— Whenever in this section an amendment or repeal is expressed in terms of an amendment to, or repeal of, a section or other provision, the reference shall be considered to be made to a section or other provision of the Federal Food, Drug, and Cosmetic Act (b) Section 201.— Paragraphs (w), (x), (y), (z), (aa), (bb), (cc), (dd), (ee), and (ff) of section 201 (21 U.S.C 321) are redesignated as paragraphs (v), (w), (x), (y), (z), (aa), (bb), (cc), (dd), and (ee) respectively. (c) Section 301.— Section 301 (21 U.S.C. 331) is amended— (1) in subsection (j), by striking out “721, or 708” and inserting in lieu thereof “708, or 721”; and (2) in subsection (s), by striking out “412(d)” and inserting in lieu thereof “412(e)”. (d) Section 302.— Section 302 (21 U.S.C. 332) is amended— (1) in subsection (a), by striking out “, and subject to” and all that follows through “381),”, and (2) in subsection (b), by striking out the second sentence. (e) Section 303.— Section 303 (21 U.S.C. 333) is amended by redesignating the second subsection (e) and subsection (f) as subsections (f) and (g), respectively. (f) Section 304.— Section 304 (21 U.S.C. 334) is amended— (1) in subsection (a)(1), by striking out “: Provided, however, That no” and inserting in lieu thereof a period and “No”, and (2) in subsection (d)(1)— (A) by striking out “: Provided, That after” and inserting in lieu thereof a period and “After”, (B) by striking out “: Provided, however, That the” and inserting in lieu thereof a period and “The”, (C) by striking out “: And provided further, That where” and inserting in lieu thereof a period and “Where”, and (D) by striking out “the foregoing proviso” and inserting in lieu thereof “the preceding sentence”. (g) Section 307.— Section 307(b)(3)(A) (21 U.S.C. 337(b)(3)(A)) is amended by striking out “Act” and inserting in lieu thereof “section”. (h) Section 401.— Section 401 (21 U.S.C. 341) is amended by striking out “and/or reasonable standards of fill of container: Provided, That no” and inserting in lieu thereof “or reasonable standards of fill of container. No”. (i) Section 402.— Section 402 (21 U.S.C. 342) is amended— (1) by striking out “; or” at the end of subparagraphs (1) and (2) of paragraph (a) and inserting in lieu thereof a period and by striking out “if it” at the beginning of subparagraph (3) of such paragraph and inserting in lieu thereof “If it”, (2) in paragraph (d)(1), by striking out “: Provided, That this clause” and inserting in lieu thereof “, except that this subparagraph”, and (3) in paragraph (d)(3), by striking out “: Provided, That this clause” and inserting in lieu thereof “, except that this subparagraph” and by striking out “: And provided further, That the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this clause” and inserting in lieu thereof “, except that the Secretary may, for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph”. (j) Section 403.— Section 403 (21 U.S.C. 343) is amended— (1) in paragraph (e), by striking out “: Provided, That” and inserting in lieu thereof “, except that”, (2) in paragraph (i), by striking out “, other than those sold as such” and inserting in lieu thereof “unless sold as spices, flavorings, or such colors” and by striking out “: Provided, That, to the extent” and inserting in lieu thereof a period and “To the extent”, (3) in paragraph (k), by striking out “: Provided, That” and inserting in lieu thereof “, except mat”, (4) in paragraph (l), by striking out “: Provided, however, That” and inserting in lieu thereof “, except that”, (5) in paragraph (r)(1)(B), by striking out “5(D)” and inserting in lieu thereof “(5)(D)”, and (6) in paragraph (r)(4)(B), by striking out “subsection” and inserting in lieu thereof “paragraph”. (k) Section 408.— Section 408 (21 U.S.C. 346a) is amended— (1) in subsection (a)(1), by striking out “Secretary of Health and Human Services” and inserting in lieu thereof “Administrator of the Environmental Protection Agency (hereinafter in this section referred to as the ‘Administrator’)”, (2) in subsection (d)(5), by striking out “section 7(c) of the Administrative Procedure Act (5 U.S.C., sec. 1006(c))” and inserting in lieu thereof “section 556(c) of title 5, United States Code”, (3) in subsection (1), by striking out “It the event” and inserting in lieu thereof “In the events”, (4) in subsection (n), by striking out “of the Federal Food, Drug, and Cosmetic Act”, (5) in subsection (o), by striking out “Secretary of Health and Human Services” each place it occurs and inserting in lieu thereof “Administrator”, and (6) by striking out “Secretary” each place it occurs except when followed by “of Agriculture” and inserting in lieu thereof “Administrator”. (l) Section 412.— Section 412(h) (21 U.S.C. 350a(h)) is amended by striking out “(c)(1)(B),” and inserting in lieu thereof “(e)(1)(B)”. (m) Section 502.— Section 502 (21 U.S.C. 352) is amended— (1) in paragraph (e)(3), by striking out “: Provided further, That” and inserting in lieu thereof “, except that”, (2) in paragraph (f), by striking out “: Provided, That” and inserting in lieu thereof “, except that”, (3) in paragraph (g), by striking out “: Provided, That the method” and inserting in lieu thereof a period and “The method” and by striking out “: Provided further, That,” and inserting in lieu thereof “, except that”, and (4) in paragraph (n), by striking out “: Provided, That” and inserting in lieu thereof “, except that”. (n) Section 505.— Section 505 (21 U.S.C. 355) is amended— (1) in subsection (j)(6)(A)— (A) by striking out “Secretry” in clause (ii) and inserting in lieu thereof “Secretary”, and (B) by inserting a comma after “Secretary” the first time it appears in clause (iii). (2) in subsection (k)(1), by striking out “: Provided, however, That regulations” and inserting in lieu thereof a period and “Regulations”. (o) Section 506.— Section 506(a) (21 U.S.C. 356(a)) is amended by striking out “Federal Security Administrator” and “Administrator” each place it appears and inserting in lieu thereof “Secretary”. (p) Section 507.— Section 507 (21 U.S.C. 357) is amended— (1) in subsection (a), by striking out “Federal Security Administrator” and “Administrator” each place it appears and inserting in lieu thereof “Secretary”, (2) in subsection (e)— (A) by striking out “section 507” each place it occurs and inserting in lieu thereof “this section”, (B) by striking out “or 507” and inserting in lieu thereof “or this section”, and (C) by striking out “: Provided, That, for purposes” and inserting in lieu thereof a period and “For purposes”, (3) in subsection (g)(1), by striking out “: Provided, however, That regulations” and inserting in lieu thereof a period and “Regulations”, and (4) in subsection (h), by striking out “507”. (q) Section 508.— Subsections (c) and (e) of section 508 (21 U.S.C. 358) are each amended by striking out “section 4 of the Administrative Procedure Act (5 U.S.C. 1003)” and inserting in lieu thereof “section 553 of title 5, United States Code”. (r) Section 512.— Section 512 (21 U.S.C. 360b) is amended— (1) in subsection (c)(2)(A)(ii), by inserting “in” after “provided”, (2) in subsection (c)(2)(F)(i), by striking out “(C)(iii)” and inserting in lieu thereof “(D)(iii)”, (3) in subsection (c)(2)(H), by striking out “subclause” the first time it appears and inserting in lieu thereof “subclauses”, (4) in subsection (d)(1), by striking out “subparagraphs (A) through (G)” and inserting in lieu thereof “subparagraphs (A) through (I)”, and (5) in subsection (n)(1)— (A) by striking out “201(w)” in subparagraphs (B)(ii)(I). and (C)(ii)(1) and inserting in lieu thereof “201(w)”, and (B) by striking out in the last sentence “(H)” and inserting in lieu thereof “(I)”. (s) Section 513.— Section 513(b)(3) (21 U.S.C 360c(b)(3)) is amended by striking out “5703(b)” and inserting in lieu thereof “5703”. (t) Section 515.— Section 515(c)(2)(A) (21 U.S.C. 360e(c)(2)(A)) is amended by striking out “refer such application”. (u) Section 519.— Section 519(a) (21 U.S.C. 360i(a)) is amended by striking out “paragraph (4)” and inserting in lieu thereof “paragraph (7)”; (v) Section 527.— Section 527(b) (21 U.S.C. 36Occ(b)) is amended— (1) by striking out “507„” and inserting in lieu thereof “507”, and (2) in paragraph (1), by striking out “The” and inserting in lieu thereof “the”. (w) Section 534.— Section 534(f)(2) (21 U.S.C. 360kk) is amended by striking out “this Act” and inserting in lieu thereof “the Public Health Service Act”. (x) Section 601.— Section 601(a) (21 U.S.C. 361) is amended by striking out “: Provided, That this” and inserting in lieu thereof “, except that this”. (y) Section 701.— Section 701 (21 U.S.C. 371) is amended— (1) in subsection (e)(1), by striking out the period after “Regulations)” the second time it occurs, and (2) in subsection (f)(4), by striking out “sections 239 and 240 of the Judicial Code, as amended” and inserting in lieu thereof “section 1254 of title 28, United States Code”. (z) Section 703.— Section 703 (21 U.S.C. 373) is amended— (1) by striking out “: Provided, That” and inserting in lieu thereof “, except that”, and (2) by striking out “: Provided further, That” and inserting in lieu thereof “, and except that”. (aa) Section 704.— Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended— (1) by striking out the semicolon after “materials” and inserting in lieu thereof a comma, and (2) by striking out “(j)” the first time it appears and inserting in lieu thereof “(k)”. (bb) Section 721.— Section 721(b)(5)(D) (21 U.S.C. 379e(b)(5)(D)) is amended by striking out “5703(b)” and inserting in lieu thereof “5703”. (cc) Section 801.— Section 801(b) (21 U.S.C. 381(b)) is amended— (1) by striking out “Administrator” the first time it occurs and inserting in lieu thereof “Secretary of Health and Human Services”, (2) by striking out “Administrator” the second and third time it occurs and inserting in lieu thereof “Secretary”, (3) by striking out “Administrator’s” and inserting in lieu thereof “Secretary’s”, and (4) by striking out “Federal Security Agency” and inserting in lieu thereof “Department of Health and Human Services”. (dd) Agriculture.— (1) Sections 201(c), 201(d), 701(b), and 801(a) (21 U.S.C. 321(c), 321(d), 371(b), and 381(a) are each amended by striking out “Agriculture” each place it appears and inserting in lieu thereof “Health and Human Services”. (2) Sections 702(c) and 706 (21 U.S.C. 372(c) and 376) are each amended by striking out “of Agriculture” each place it appears.

10. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 412(b) · 111 Stat. 2296

    Substituted · 21 U.S.C. § 374(a)(1)

    Pub. L. 105–115, § 412(b), substituted “prescription drugs, nonprescription drugs intended for human use,” for “prescription drugs” in two places

    Source evidence

    Code amendment note
    Subsec. (a)(1). Pub. L. 105–115, § 412(b), substituted “prescription drugs, nonprescription drugs intended for human use,” for “prescription drugs” in two places.

    Enacted provision · exact public law section
    (b) Inspections.— Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended by striking “prescription drugs” each place it appears and inserting “prescription drugs, nonprescription drugs intended for human use,”.

11. 1997

    Food and Drug Administration Modernization Act of 1997

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

    Struck · 21 U.S.C. § 374(a)(1)

    Pub. L. 105–115, § 125(b)(2)(L), struck out “, section 357(d) or (g),” before “section 360i”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 105–115, § 125(b)(2)(L), struck out “, section 357(d) or (g),” before “section 360i”.

    Enacted provision · exact public law section
    (L) Section 704(a)(1) (21 U.S.C. 374(a)(1)) is amended by striking “, section 507 (d) or (g),”.

12. 1997

    Food and Drug Administration Modernization Act of 1997

    Pub. L. 105–115 § 210(b) · 111 Stat. 2296

    Added · 21 U.S.C. § 374(f)

    Pub. L. 105–115, § 210(b), added subsec. (f)

    Source evidence

    Code amendment note
    Subsec. (f). Pub. L. 105–115, § 210(b), added subsec. (f).

    Enacted provision · exact public law section
    (b) Recordkeeping.— Section 704 (21 U.S.C. 374) is amended by adding at the end the following: “(f) (1) A person accredited under section 523 to review reports made under section 510(k) and make recommendations of initial classifications of devices to the Secretary shall maintain records documenting the training qualifications of the person and the employees of the person, the procedures used by the person for handling confidential information, the compensation arrangements made by the person, and the procedures used by the person to identify and avoid conflicts of interest. Upon the request of an officer or employee designated by the Secretary, the person shall permit the officer or employee, at all reasonable times, to have access to, to copy, and to verify, the records. “(2) Within 15 days after the receipt of a written request from the Secretary to a person accredited under section 523 for copies of records described in paragraph (1), the person shall produce the copies of the records at the place designated by the Secretary.”.

13. 2002

    Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 § 306(b)(1) · 116 Stat. 594

    Inserted · 21 U.S.C. § 374(a)(1)

    Pub. L. 107–188, § 306(b)(1), inserted after first sentence “In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to the limitations established in section 350c(d) of this title.”

    Source evidence

    Code amendment note
    Subsec. (a)(1). Pub. L. 107–188, § 306(b)(1), inserted after first sentence “In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 350c of this title when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to the limitations established in section 350c(d) of this title.”

    Enacted provision · exact public law section
    (1) in paragraph (1), by inserting after the first sentence the following new sentence: “In the case of any person (excluding farms and restaurants) who manufactures, processes, packs, transports, distributes, holds, or imports foods, the inspection shall extend to all records and other information described in section 414 when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to the limitations established in section 414(d).”; and

14. 2002

    Public Health Security and Bioterrorism Preparedness and Response Act of 2002”

    Pub. L. 107–188 § 306(b)(2) · 116 Stat. 594

    Substituted · 21 U.S.C. § 374(a)(2)

    Pub. L. 107–188, § 306(b)(2), substituted “third sentence” for “second sentence” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (a)(2). Pub. L. 107–188, § 306(b)(2), substituted “third sentence” for “second sentence” in introductory provisions.

    Enacted provision · exact public law section
    (2) in paragraph (2), in the matter preceding subparagraph (A), by striking “second sentence” and inserting “third sentence”.

15. 2002

    Medical Device User Fee and Modernization Act of 2002

    Pub. L. 107–250 § 201(b)(1) · 116 Stat. 1588

    Substituted · 21 U.S.C. § 374(f)(1)

    Pub. L. 107–250, § 201(b)(1), in first sentence, substituted “An accredited person described in paragraph (3) shall maintain records” for “A person accredited under section 360m of this title to review reports made under section 360(k) of this title and make recommendations of initial classifications of devices to the Secretary shall maintain records”

    Source evidence

    Code amendment note
    Subsec. (f)(1). Pub. L. 107–250, § 201(b)(1), in first sentence, substituted “An accredited person described in paragraph (3) shall maintain records” for “A person accredited under section 360m of this title to review reports made under section 360(k) of this title and make recommendations of initial classifications of devices to the Secretary shall maintain records”.

    Enacted provision · exact public law section
    (1) in paragraph (1), in the first sentence, by striking “A person accredited” and all that follows through “shall maintain records” and inserting the following: “An accredited person described in paragraph (3) shall maintain records”;

16. 2002

    Medical Device User Fee and Modernization Act of 2002

    Pub. L. 107–250 § 201(b)(2) · 116 Stat. 1588

    Substituted · 21 U.S.C. § 374(f)(2)

    Pub. L. 107–250, § 201(b)(2), substituted “an accredited person described in paragraph (3)” for “a person accredited under section 360m of this title”

    Source evidence

    Code amendment note
    Subsec. (f)(2). Pub. L. 107–250, § 201(b)(2), substituted “an accredited person described in paragraph (3)” for “a person accredited under section 360m of this title”.

    Enacted provision · exact public law section
    (2) in paragraph (2), by striking “a person accredited under section 523” and inserting “an accredited person described in paragraph (3)”; and

17. 2002

    Medical Device User Fee and Modernization Act of 2002

    Pub. L. 107–250 § 201(b)(3) · 116 Stat. 1588

    Added · 21 U.S.C. § 374(f)(3)

    Pub. L. 107–250, § 201(b)(3), added par. (3)

    Source evidence

    Code amendment note
    Subsec. (f)(3). Pub. L. 107–250, § 201(b)(3), added par. (3).

    Enacted provision · exact public law section
    (3) by adding at the end the following paragraph: “(3) For purposes of paragraphs (1) and (2), an accredited person described in this paragraph is a person who— “(A) is accredited under subsection (g); or “(B) is accredited under section 523.”.

18. 2002

    Medical Device User Fee and Modernization Act of 2002

    Pub. L. 107–250 § 201(a) · 116 Stat. 1588

    Added · 21 U.S.C. § 374(g)

    Pub. L. 107–250, § 201(a), added subsec. (g)

    Source evidence

    Code amendment note
    Subsec. (g). Pub. L. 107–250, § 201(a), added subsec. (g).

    Enacted provision · exact public law section
    (a) In General.— Section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) is amended by adding at the end the following subsection: “(g) (1) Not later than one year after the date of the enactment of this subsection, the Secretary shall, subject to the provisions of this subsection, accredit persons for the purpose of conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices that are required in section 510(h), or inspections of such establishments required to register pursuant to section 510(i). The owner or operator of such an establishment that is eligible under paragraph (6) may, from the list published under paragraph (4), select an accredited person to conduct such inspections. “(2) Not later than 180 days after the date of enactment of this subsection, the Secretary shall publish in the Federal Register criteria to accredit or deny accreditation to persons who request to perform the duties specified in paragraph (1). Thereafter, the Secretary shall inform those requesting accreditation, within 60 days after the receipt of such request, whether the request for accreditation is adequate for review, and the Secretary shall promptly act on the request for accreditation. Any resulting accreditation shall state that such person is accredited to conduct inspections at device establishments identified in paragraph (1). The accreditation of such person shall specify the particular activities under this subsection for which such person is accredited. In the first year following the publication in the Federal Register of criteria to accredit or deny accreditation to persons who request to perform the duties specified in paragraph (1), the Secretary shall accredit no more than 15 persons who request to perform duties specified in paragraph (1). “(3) An accredited person shall, at a minimum, meet the following requirements: “(A) Such person may not be an employee of the Federal Government. “(B) Such person shall be an independent organization which is not owned or controlled by a manufacturer, supplier, or vendor of articles regulated under this Act and which has no organizational, material, or financial affiliation (including a consultative affiliation) with such a manufacturer, supplier, or vendor. “(C) Such person shall be a legally constituted entity permitted to conduct the activities for which it seeks accreditation. “(D) Such person shall not engage in the design, manufacture, promotion, or sale of articles regulated under this Act. “(E) The operations of such person shall be in accordance with generally accepted professional and ethical business practices, and such person shall agree in writing that at a minimum the person will— “(i) certify that reported information accurately reflects data reviewed, inspection observations made, other matters that relate to or may influence compliance with this Act, and recommendations made during an inspection or at an inspection’s closing meeting; “(ii) limit work to that for which competence and capacity are available; “(iii) treat information received, records, reports, and recommendations as confidential commercial or financial information or trade secret information, except such information may be made available to the Secretary; “(iv) promptly respond and attempt to resolve complaints regarding its activities for which it is accredited; and “(v) protect against the use, in carrying out paragraph (1), of any officer or employee of the accredited person who has a financial conflict of interest regarding any product regulated under this Act, and annually make available to the public disclosures of the extent to which the accredited person, and the officers and employees of the person, have maintained compliance with requirements under this clause relating to financial conflicts of interest. “(4) The Secretary shall publish on the Internet site of the Food and Drug Administration a list of persons who are accredited under paragraph (2). Such list shall be updated to ensure that the identity of each accredited person, and the particular activities for which the person is accredited, is known to the public. The updating of such list shall be no later than one month after the accreditation of a person under this subsection or the suspension or withdrawal of accreditation, or the modification of the particular activities for which the person is accredited. “(5) (A) To ensure that persons accredited under this subsection continue to meet the standards of accreditation, the Secretary shall (i) audit the performance of such persons on a periodic basis through the review of inspection reports and inspections by persons designated by the Secretary to evaluate the compliance status of a device establishment and the performance of accredited persons, and (ii) take such additional measures as the Secretary determines to be appropriate. “(B) The Secretary may withdraw accreditation of any person accredited under paragraph (2), after providing notice and an opportunity for an informal hearing, when such person is substantially not in compliance with the standards of accreditation, or poses a threat to public health or fails to act in a manner that is consistent with the purposes of this subsection. The Secretary may suspend the accreditation of such person during the pendency of the process under the preceding sentence. “(6) (A) Subject to subparagraphs (B) and (C), a device establishment is eligible for inspections by persons accredited under paragraph (2) if the following conditions are met: “(i) The Secretary classified the results of the most recent inspection of the establishment pursuant to subsection (h) or (i) of section 510 as ‘no action indicated’ or ‘voluntary action indicated’. “(ii) With respect to each inspection to be conducted by an accredited person— “(I) the owner or operator of the establishment submits to the Secretary a notice requesting clearance to use such a person to conduct the inspection, and the Secretary provides such clearance; and “(II) such notice identifies the accredited person whom the establishment has selected to conduct the inspection, and the Secretary agrees to the selected accredited person. “(iii) With respect to the devices that are manufactured, prepared, propagated, compounded, or processed by the establishment, at least one of such devices is marketed in the United States, and the following additional conditions are met: “(I) At least one of such devices is marketed, or is intended to be marketed, in one or more foreign countries, one of which countries certifies, accredits, or otherwise recognizes the person accredited under paragraph (2) and identified under subclause (II) of this clause. “(II) The owner or operator of the establishment submits to the Secretary a statement that the law of a country in which such a device is marketed, or is intended to be marketed, recognizes an inspection of the establishment by the Secretary, and not later than 30 days after receiving such statement, the Secretary informs the owner or operator of the establishment that the owner or operator may submit a notice requesting clearance under clause (ii). “(iv) (I) In the case of an inspection to be conducted pursuant to 510(h), persons accredited under paragraph (2) did not conduct the two immediately preceding inspections of the establishment, except that the establishment may petition the Secretary for a waiver of such condition. Such a waiver may be granted only if the petition states a commercial reason for the waiver; the Secretary determines that the public health would be served by granting the waiver; and the Secretary has conducted an inspection of the establishment during the four-year period preceding the date on which the notice under clause (ii) is submitted to the Secretary. Such a waiver is deemed to be granted only if the petition states a commercial reason for the waiver; the Secretary has not determined that the public health would be served by granting the waiver; and the owner or operator of the device establishment has requested in writing, not later than 18 months following the most recent inspection of such establishment by a person accredited under paragraph (2), that the Secretary inspect the establishment and the Secretary has not conducted an inspection within 30 months after the most recent inspection. With respect to such a waiver that is granted or deemed to be granted, no additional such waiver may be granted until after the Secretary has conducted an inspection of the establishment. “(II) In the case of an inspection to be conducted pursuant to 510(i), the Secretary periodically conducts inspections of the establishment. “(B) (i) The Secretary shall respond to a notice under subparagraph (A) from a device establishment not later than 30 days after the Secretary receives the notice. Through such response, the Secretary shall (I) provide clearance under such subparagraph, and agree to the selection of an accredited person, or (II) make a request under clause (ii). If the Secretary fails to respond to the notice within such 30-day period, the establishment is deemed to have such clearance, and to have the agreement of the Secretary for such selection. “(ii) The request referred to in clause (i)(II) is— “(I) a request to the device establishment involved to submit to the Secretary compliance data in accordance with clause (iii); or “(II) a request to the establishment, or to the accredited person identified in the notice under subparagraph (A), for information concerning the relationship between the establishment and such accredited person, including information about the number of inspections of the establishment, or other establishments owned or operated by the owner or operator of the establishment, that have been conducted by the accredited person. The Secretary may make both such requests. “(iii) The compliance data to be submitted by a device establishment under clause (ii) are data describing whether the quality controls of the establishment have been sufficient for ensuring consistent compliance with current good manufacturing practice within the meaning of section 501(h), and data otherwise describing whether the establishment has consistently been in compliance with sections 501 and 502 and other applicable provisions of this Act. Such data shall include complete reports of inspections regarding good manufacturing practice or other quality control audits that, during the preceding two-year period, were conducted at the establishment by persons other than the owner or operator of the establishment, together with all other compliance data the Secretary deems necessary. Data under the preceding sentence shall demonstrate to the Secretary whether the establishment has facilitated consistent compliance by promptly correcting any compliance problems identified in such inspections. “(iv) Not later than 60 days after receiving compliance data under clause (iii) from a device establishment, the Secretary shall provide or deny clearance under subparagraph (A). The Secretary may deny clearance if the Secretary determines that the establishment has failed to demonstrate consistent compliance for purposes of clause (iii). The Secretary shall provide to the establishment a statement of such reasons for such determination. If the Secretary fails to provide such statement to the establishment within such 60-day period, the establishment is deemed to have such clearance. “(v) (I) A request to an accredited person under clause (ii)(II) may not seek any information that is not required to be maintained by such person in records under subsection (f)(1). Not later than 60 days after receiving the information sought by the request, the Secretary shall agree to, or reject, the selection of such person by the device establishment involved. The Secretary may reject the selection if the Secretary provides to the establishment a statement of the reasons for such rejection. Reasons for the rejection may include that the establishment or the accredited person, as the case may be, has failed to fully respond to the request, or that the Secretary has concerns regarding the relationship between the establishment and such accredited person. If within such 60-day period the Secretary fails to agree to or reject the selection in accordance with this subclause, the Secretary is deemed to have agreed to the selection. “(II) If the Secretary rejects the selection of an accredited person by a device establishment, the establishment may make an additional selection of an accredited person by submitting to the Secretary a notice that identifies the additional selection. Clauses (i) and (ii), and subclause (I) of this clause, apply to the selection of an accredited person through a notice under the preceding sentence in the same manner and to the same extent as such provisions apply to a selection of an accredited person through a notice under subparagraph (A). “(vi) In the case of a device establishment that under clause (iv) is denied clearance under subparagraph (A), or whose selection of an accredited person is rejected under clause (v), the Secretary shall designate a person to review the findings of the Secretary under such clause if, during the 30-day period beginning on the date on which the establishment receives the findings, the establishment requests the review. The review shall commence not later than 30 days after the establishment requests the review, unless the Secretary and the establishment otherwise agree. “(C) (i) In the case of a device establishment for which the Secretary classified the results of the most recent inspection of the establishment by a person accredited under paragraph (2) as ‘official action indicated’, the establishment, if otherwise eligible under subparagraph (A), is eligible for further inspections by persons accredited under such paragraph if (I) the Secretary issues a written statement to the owner or operator of the establishment that the violations leading to such classification have been resolved, and (II) the Secretary, either upon the Secretary’s own initiative or a petition of the owner or operator of the establishment, notifies the establishment that it has clearance to use an accredited person for the inspections. The Secretary shall respond to such petition within 30 days after the receipt of the petition. “(ii) If the Secretary denies a petition under clause (i), the device establishment involved may, after the expiration of one year after such denial, again petition the Secretary for a determination of eligibility for inspection by persons accredited by the Secretary under paragraph (2). If the Secretary denies such petition, the Secretary shall provide the establishment with such reasons for such denial within 60 days after the denial. If, as of the expiration of 48 months after the receipt of the first petition, the establishment has not been inspected by the Secretary in accordance with section 510(h), or has not during such period been inspected pursuant to section 510(i), as applicable, the establishment is eligible for further inspections by accredited persons. “(7) (A) Persons accredited under paragraph (2) to conduct inspections shall record in writing their inspection observations and shall present the observations to the device establishment’s designated representative and describe each observation. Additionally, such accredited person shall prepare an inspection report (including for inspections classified as ‘no action indicated’) in a form and manner consistent with such reports prepared by employees and officials designated by the Secretary to conduct inspections. “(B) At a minimum, an inspection report under subparagraph (A) shall identify the persons responsible for good manufacturing practice compliance at the inspected device establishment, the dates of the inspection, the scope of the inspection, and shall describe in detail each observation identified by the accredited person, identify other matters that relate to or may influence compliance with this Act, and describe any recommendations during the inspection or at the inspection’s closing meeting. “(C) An inspection report under subparagraph (A) shall be sent to the Secretary and to the designated representative of the inspected device establishment at the same time, but under no circumstances later than three weeks after the last day of the inspection. The report to the Secretary shall be accompanied by all written inspection observations previously provided to the designated representative of the establishment. “(D) Any statement or representation made by an employee or agent of a device establishment to a person accredited under paragraph (2) to conduct inspections shall be subject to section 1001 of title 18, United States Code. “(E) If at any time during an inspection by an accredited person the accredited person discovers a condition that could cause or contribute to an unreasonable risk to the public health, the accredited person shall immediately notify the Secretary of the identification of the device establishment subject to inspection and such condition. “(8) Compensation for an accredited person shall be determined by agreement between the accredited person and the person who engages the services of the accredited person, and shall be paid by the person who engages such services. “(9) Nothing in this subsection affects the authority of the Secretary to inspect any device establishment pursuant to this Act. “(10) (A) For fiscal year 2005 and each subsequent fiscal year, no device establishment may be inspected during the fiscal year involved by a person accredited under paragraph (2) if— “(i) of the amounts appropriated for salaries and expenses of the Food and Drug Administration for the preceding fiscal year (referred to in this subparagraph as the ‘first prior fiscal year’), the amount obligated by the Secretary for inspections of device establishments by the Secretary was less than the adjusted base amount applicable to such first prior fiscal year; and “(ii) of the amounts appropriated for salaries and expenses of the Food and Drug Administration for the fiscal year preceding the first prior fiscal year (referred to in this subparagraph as the ‘second prior fiscal year’), the amount obligated by the Secretary for inspections of device establishments by the Secretary was less than the adjusted base amount applicable to such second prior fiscal year. “(B) (i) Subject to clause (ii), the Comptroller General of the United States shall determine the amount that was obligated by the Secretary for fiscal year 2002 for compliance activities of the Food and Drug Administration with respect to devices (referred to in this subparagraph as the ‘compliance budget’), and of such amount, the amount that was obligated for inspections by the Secretary of device establishments (referred to in this subparagraph as the ‘inspection budget’). “(ii) For purposes of determinations under clause (i), the Comptroller General shall not include in the compliance budget or the inspection budget any amounts obligated for inspections of device establishments conducted as part of the process of reviewing applications under section 515. “(iii) Not later than March 31, 2003, the Comptroller General shall complete the determinations required in this subparagraph and submit to the Secretary and the Congress a reporting describing the findings made through such determinations. “(C) For purposes of this paragraph: “(i) The term ‘base amount’ means the inspection budget determined under subparagraph (B) for fiscal year 2002. “(ii) The term ‘adjusted base amount’, in the case of applicability to fiscal year 2003, means an amount equal to the base amount increased by 5 percent. “(iii) The term ‘adjusted base amount’, with respect to applicability to fiscal year 2004 or any subsequent fiscal year, means the adjusted based amount applicable to the preceding year increased by 5 percent. “(11) The authority provided by this subsection terminates on October 1, 2012. “(12) No later than four years after the enactment of this subsection the Comptroller General shall report to the Committee on Energy and Commerce of the House of Representatives and the Committee on Health, Education, Labor and Pensions of the Senate— “(A) the number of inspections pursuant to subsections (h) and (i) of section 510 conducted by accredited persons and the number of inspections pursuant to such subsections conducted by Federal employees; “(B) the number of persons who sought accreditation under this subsection, as well as the number of persons who were accredited under this subsection; “(C) the reasons why persons who sought accreditation, but were denied accreditation, were denied; “(D) the number of audits conducted by the Secretary of accredited persons, the quality of inspections conducted by accredited persons, whether accredited persons are meeting their obligations under this Act, and whether the number of audits conducted is sufficient to permit these assessments; “(E) whether this subsection is achieving the goal of ensuring more information about device establishment compliance is being presented to the Secretary, and whether that information is of a quality consistent with information obtained by the Secretary pursuant to subsection (h) or (i) of section 510; “(F) whether this subsection is advancing efforts to allow device establishments to rely upon third-party inspections for purposes of compliance with the laws of foreign governments; and “(G) whether the Congress should continue, modify, or terminate the program under this subsection. “(13) The Secretary shall include in the annual report required under section 903(g) the names of all accredited persons and the particular activities under this subsection for which each such person is accredited and the name of each accredited person whose accreditation has been withdrawn during the year. “(14) Notwithstanding any provision of this subsection, this subsection does not have any legal effect on any agreement described in section 803(b) between the Secretary and a foreign country.”.

19. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(A) · 118 Stat. 572

    Substituted · 21 U.S.C. § 374(g)(1)

    Pub. L. 108–214, § 2(b)(1)(A), in first sentence, substituted “conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices, which inspections are required under section 360(h) of this title or are inspections of such establishments required to register under section 360(i) of this title.” for “conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices that are required in section 360(h) of this title, or inspections of such establishments required to register pursuant to section 360(i) of this title.”

    Source evidence

    Code amendment note
    Subsec. (g)(1). Pub. L. 108–214, § 2(b)(1)(A), in first sentence, substituted “conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices, which inspections are required under section 360(h) of this title or are inspections of such establishments required to register under section 360(i) of this title.” for “conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices that are required in section 360(h) of this title, or inspections of such establishments required to register pursuant to section 360(i) of this title.”

    Enacted provision · exact public law section
    (A) in paragraph (1), in the first sentence, by striking “conducting inspections” and all that follows and inserting “conducting inspections of establishments that manufacture, prepare, propagate, compound, or process class II or class III devices, which inspections are required under section 510(h) or are inspections of such establishments required to register under section 510(i).”;

20. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(B) · 118 Stat. 572

    Substituted · 21 U.S.C. § 374(g)(5)(B)

    Pub. L. 108–214, § 2(b)(1)(B), in first sentence, substituted “poses a threat to public health, fails to act in a manner that is consistent with the purposes of this subsection, or where the Secretary determines that there is a financial conflict of interest in the relationship between the accredited person and the owner or operator of a device establishment that the accredited person has inspected under this subsection.” for “or poses a threat to public health or fails to act in a manner that is consistent with the purposes of this subsection.”

    Source evidence

    Code amendment note
    Subsec. (g)(5)(B). Pub. L. 108–214, § 2(b)(1)(B), in first sentence, substituted “poses a threat to public health, fails to act in a manner that is consistent with the purposes of this subsection, or where the Secretary determines that there is a financial conflict of interest in the relationship between the accredited person and the owner or operator of a device establishment that the accredited person has inspected under this subsection.” for “or poses a threat to public health or fails to act in a manner that is consistent with the purposes of this subsection.”

    Enacted provision · exact public law section
    (B) in paragraph (5)(B), in the first sentence, by striking “or poses” and all that follows through the period and inserting “poses a threat to public health, fails to act in a manner that is consistent with the purposes of this subsection, or where the Secretary determines that there is a financial conflict of interest in the relationship between the accredited person and the owner or operator of a device establishment that the accredited person has inspected under this subsection.”;

21. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(C)(i) · 118 Stat. 572

    Substituted · 21 U.S.C. § 374(g)(6)(A)(i)

    Pub. L. 108–214, § 2(b)(1)(C)(i), substituted “described in paragraph (1)” for “of the establishment pursuant to subsection (h) or (i) of section 360 of this title”

    Source evidence

    Code amendment note
    Subsec. (g)(6)(A)(i). Pub. L. 108–214, § 2(b)(1)(C)(i), substituted “described in paragraph (1)” for “of the establishment pursuant to subsection (h) or (i) of section 360 of this title”.

    Enacted provision · exact public law section
    (i) in clause (i), by striking “of the establishment pursuant to subsection (h) or (i) of section 510” and inserting “described in paragraph (1)”;

22. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(C)(ii)(I) · 118 Stat. 572

    1. Substituted · 21 U.S.C. § 374(g)(6)(A)(ii)

       Pub. L. 108–214, § 2(b)(1)(C)(ii)(I), substituted “inspections” for “each inspection”

    2. Inserted · 21 U.S.C. § 374(g)(6)(A)(ii)

       Pub. L. 108–214, § 2(b)(1)(C)(ii)(I), inserted “during a 2-year period” after “person” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (g)(6)(A)(ii). Pub. L. 108–214, § 2(b)(1)(C)(ii)(I), substituted “inspections” for “each inspection” and inserted “during a 2-year period” after “person” in introductory provisions.

    Enacted provision · exact public law section
    (I) in the matter preceding subclause (I)— (aa) by striking “each inspection” and inserting “inspections”; and (bb) by inserting “during a 2-year period” after “person”; and

23. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(C)(ii)(II) · 118 Stat. 572

    Substituted · 21 U.S.C. § 374(g)(6)(A)(ii)(I)

    Pub. L. 108–214, § 2(b)(1)(C)(ii)(II), substituted “an accredited person” for “such a person”

    Source evidence

    Code amendment note
    Subsec. (g)(6)(A)(ii)(I). Pub. L. 108–214, § 2(b)(1)(C)(ii)(II), substituted “an accredited person” for “such a person”.

    Enacted provision · exact public law section
    (II) in subclause (I), by striking “such a person” and inserting “an accredited person”;

24. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(C)(iii)(I) · 118 Stat. 572

    Substituted · 21 U.S.C. § 374(g)(6)(A)(iii)

    Pub. L. 108–214, § 2(b)(1)(C)(iii)(I), substituted “and 1 or both of the following additional conditions are met:” for “and the following additional conditions are met:” in introductory provisions

    Source evidence

    Code amendment note
    Subsec. (g)(6)(A)(iii). Pub. L. 108–214, § 2(b)(1)(C)(iii)(I), substituted “and 1 or both of the following additional conditions are met:” for “and the following additional conditions are met:” in introductory provisions.

    Enacted provision · exact public law section
    (I) in the matter preceding subclause (I), by striking “and the following additional conditions are met:” and inserting “and 1 or both of the following additional conditions are met:”;

25. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(C)(iii)(II) · 118 Stat. 572

    Substituted · 21 U.S.C. § 374(g)(6)(A)(iii)(I)

    Pub. L. 108–214, § 2(b)(1)(C)(iii)(II), substituted “(accredited under paragraph (2) and identified under clause (ii)(II)) as a person authorized to conduct such inspections of device establishments.” for “accredited under paragraph (2) and identified under subclause (II) of this clause.”

    Source evidence

    Code amendment note
    Subsec. (g)(6)(A)(iii)(I). Pub. L. 108–214, § 2(b)(1)(C)(iii)(II), substituted “(accredited under paragraph (2) and identified under clause (ii)(II)) as a person authorized to conduct such inspections of device establishments.” for “accredited under paragraph (2) and identified under subclause (II) of this clause.”

    Enacted provision · exact public law section
    (II) in subclause (I), by striking “accredited” and all that follows through the period and inserting “(accredited under paragraph (2) and identified under clause (ii)(II)) as a person authorized to conduct such inspections of device establishments.”; and

26. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(C)(iii)(III) · 118 Stat. 572

    Inserted · 21 U.S.C. § 374(g)(6)(A)(iii)(II)

    Pub. L. 108–214, § 2(b)(1)(C)(iii)(III), inserted “or by a person accredited under paragraph (2)” after “by the Secretary”

    Source evidence

    Code amendment note
    Subsec. (g)(6)(A)(iii)(II). Pub. L. 108–214, § 2(b)(1)(C)(iii)(III), inserted “or by a person accredited under paragraph (2)” after “by the Secretary”.

    Enacted provision · exact public law section
    (III) in subclause (II), by inserting “or by a person accredited under paragraph (2)” after “by the Secretary”;

27. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(C)(iv) · 118 Stat. 572

    1. Inserted · 21 U.S.C. § 374(g)(6)(A)(iv)(I)

       Pub. L. 108–214, § 2(b)(1)(C)(iv), in first sentence, inserted “section” after “pursuant to”

    2. Substituted · 21 U.S.C. § 374(g)(6)(A)(iv)(I)

       Pub. L. 108–214, § 2(b)(1)(C)(iv), in first sentence, substituted “inspections of the establishment during the previous 4 years” for “the two immediately preceding inspections of the establishment”, in third sentence

    3. Struck and inserted · 21 U.S.C. § 374(g)(6)(A)(iv)(I)

       Pub. L. 108–214, § 2(b)(1)(C)(iv), in first sentence, struck out “the petition states a commercial reason for the waiver;” after “granted only if” and inserted “not” after “the Secretary has not determined that the public health would”, and, in last sentence

    4. Substituted · 21 U.S.C. § 374(g)(6)(A)(iv)(I)

       Pub. L. 108–214, § 2(b)(1)(C)(iv), in first sentence, substituted “granted or deemed to be granted until” for “granted until”

    Source evidence

    Code amendment note
    Subsec. (g)(6)(A)(iv)(I). Pub. L. 108–214, § 2(b)(1)(C)(iv), in first sentence, inserted “section” after “pursuant to” and substituted “inspections of the establishment during the previous 4 years” for “the two immediately preceding inspections of the establishment”, in third sentence, struck out “the petition states a commercial reason for the waiver;” after “granted only if” and inserted “not” after “the Secretary has not determined that the public health would”, and, in last sentence, substituted “granted or deemed to be granted until” for “granted until”.

    Enacted provision · exact public law section
    (iv) in clause (iv)(I)— (I) in the first sentence— (aa) by striking “the two immediately preceding inspections of the establishment” and inserting “inspections of the establishment during the previous 4 years”; and (bb) by inserting “section” after “pursuant to”; (II) in the third sentence— (aa) by striking “the petition states a commercial reason for the waiver;”; and (bb) by inserting “not” after “the Secretary has not determined that the public health would”; and (III) in the fourth sentence, by striking “granted until” and inserting “granted or deemed to be granted until”; and

28. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(C)(v) · 118 Stat. 572

    Inserted · 21 U.S.C. § 374(g)(6)(A)(iv)(II)

    Pub. L. 108–214, § 2(b)(1)(C)(v), inserted “of a device establishment required to register” after “to be conducted” and “section” after “pursuant to”

    Source evidence

    Code amendment note
    Subsec. (g)(6)(A)(iv)(II). Pub. L. 108–214, § 2(b)(1)(C)(v), inserted “of a device establishment required to register” after “to be conducted” and “section” after “pursuant to”.

    Enacted provision · exact public law section
    (v) in clause (iv)(II)— (I) by inserting “of a device establishment required to register” after “to be conducted”; and (II) by inserting “section” after “pursuant to”;

29. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(D) · 118 Stat. 572

    1. Substituted · 21 U.S.C. § 374(g)(6)(B)(iii)

       Pub. L. 108–214, § 2(b)(1)(D), in first sentence, substituted “and with other” for “, and data otherwise describing whether the establishment has consistently been in compliance with sections 351 and 352 of this title and other” and, in second sentence

    2. Substituted · 21 U.S.C. § 374(g)(6)(B)(iii)

       Pub. L. 108–214, § 2(b)(1)(D), in first sentence, substituted “inspectional findings” for “inspections”

    3. Inserted · 21 U.S.C. § 374(g)(6)(B)(iii)

       Pub. L. 108–214, § 2(b)(1)(D), in first sentence, inserted “relevant” after “together with all other”

    Source evidence

    Code amendment note
    Subsec. (g)(6)(B)(iii). Pub. L. 108–214, § 2(b)(1)(D), in first sentence, substituted “and with other” for “, and data otherwise describing whether the establishment has consistently been in compliance with sections 351 and 352 of this title and other” and, in second sentence, substituted “inspectional findings” for “inspections” and inserted “relevant” after “together with all other”.

    Enacted provision · exact public law section
    (D) in paragraph (6)(B)(iii)— (i) in the first sentence, by striking “, and data otherwise describing whether the establishment has consistently been in compliance with sections 501 and 502 and other” and inserting “and with other”; and (ii) in the second sentence— (I) by striking “inspections” and inserting “inspectional findings”; and (II) by inserting “relevant” after “together with all other”;

30. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(E) · 118 Stat. 572

    1. Amended · 21 U.S.C. § 374(g)(6)(B)(iv)

       Pub. L. 108–214, § 2(b)(1)(E), designated existing provisions as subcl. (I)

    2. Added · 21 U.S.C. § 374(g)(6)(B)(iv)

       Pub. L. 108–214, § 2(b)(1)(E), added subcl. (II)

    Source evidence

    Code amendment note
    Subsec. (g)(6)(B)(iv). Pub. L. 108–214, § 2(b)(1)(E), designated existing provisions as subcl. (I) and added subcl. (II).

    Enacted provision · exact public law section
    (E) in paragraph (6)(B)(iv)— (i) by inserting “(I)” after “(iv)”; and (ii) by adding at the end the following: “(II) If, during the two-year period following clearance under subparagraph (A), the Secretary determines that the device establishment is substantially not in compliance with this Act, the Secretary may, after notice and a written response, notify the establishment that the eligibility of the establishment for the inspections by accredited persons has been suspended.” ;

31. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(F) · 118 Stat. 572

    Struck · 21 U.S.C. § 374(g)(6)(C)(ii)

    Pub. L. 108–214, § 2(b)(1)(F), struck out “in accordance with section 360(h) of this title, or has not during such period been inspected pursuant to section 360(i) of this title, as applicable” after “inspected by the Secretary”

    Source evidence

    Code amendment note
    Subsec. (g)(6)(C)(ii). Pub. L. 108–214, § 2(b)(1)(F), struck out “in accordance with section 360(h) of this title, or has not during such period been inspected pursuant to section 360(i) of this title, as applicable” after “inspected by the Secretary”.

    Enacted provision · exact public law section
    (F) in paragraph (6)(C)(ii), by striking “in accordance with section 510(h), or has not during such period been inspected pursuant to section 510(i), as applicable”;

32. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(G) · 118 Stat. 572

    Substituted · 21 U.S.C. § 374(g)(10)(B)(iii)

    Pub. L. 108–214, § 2(b)(1)(G), substituted “a report” for “a reporting”

    Source evidence

    Code amendment note
    Subsec. (g)(10)(B)(iii). Pub. L. 108–214, § 2(b)(1)(G), substituted “a report” for “a reporting”.

    Enacted provision · exact public law section
    (G) in paragraph (10)(B)(iii), by striking “a reporting” and inserting “a report”; and

33. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(H)(i) · 118 Stat. 572

    1. Added · 21 U.S.C. § 374(g)(12)(A)

       Pub. L. 108–214, § 2(b)(1)(H)(i), added subpar. (A)

    2. Struck · 21 U.S.C. § 374(g)(12)(A)

       Pub. L. 108–214, § 2(b)(1)(H)(i), struck out former subpar. (A) which read as follows: “the number of inspections pursuant to subsections (h) and (i) of section 360 of this title conducted by accredited persons and the number of inspections pursuant to such subsections conducted by Federal employees;”

    Source evidence

    Code amendment note
    Subsec. (g)(12)(A). Pub. L. 108–214, § 2(b)(1)(H)(i), added subpar. (A) and struck out former subpar. (A) which read as follows: “the number of inspections pursuant to subsections (h) and (i) of section 360 of this title conducted by accredited persons and the number of inspections pursuant to such subsections conducted by Federal employees;”.

    Enacted provision · exact public law section
    (i) by striking subparagraph (A) and inserting the following: “(A) the number of inspections conducted by accredited persons pursuant to this subsection and the number of inspections conducted by Federal employees pursuant to section 510(h) and of device establishments required to register under section 510(i);” ; and

34. 2004

    Medical Devices Technical Corrections Act

    Pub. L. 108–214 § 2(b)(1)(H)(ii) · 118 Stat. 572

    Substituted · 21 U.S.C. § 374(g)(12)(E)

    Pub. L. 108–214, § 2(b)(1)(H)(ii), substituted “obtained by the Secretary pursuant to inspections conducted by Federal employees;” for “obtained by the Secretary pursuant to subsection (h) or (i) of section 360 of this title;”

    Source evidence

    Code amendment note
    Subsec. (g)(12)(E). Pub. L. 108–214, § 2(b)(1)(H)(ii), substituted “obtained by the Secretary pursuant to inspections conducted by Federal employees;” for “obtained by the Secretary pursuant to subsection (h) or (i) of section 360 of this title;”.

    Enacted provision · exact public law section
    (ii) in subparagraph (E), by striking “obtained by the Secretary” and all that follows and inserting “obtained by the Secretary pursuant to inspections conducted by Federal employees;”.

35. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 228(1) · 121 Stat. 823

    Substituted · 21 U.S.C. § 374(g)(1)

    Pub. L. 110–85, § 228(1), substituted “The Secretary” for “Not later than one year after October 26, 2002, the Secretary”

    Source evidence

    Code amendment note
    Subsec. (g)(1). Pub. L. 110–85, § 228(1), substituted “The Secretary” for “Not later than one year after October 26, 2002, the Secretary”.

    Enacted provision · exact public law section
    (1) in paragraph (1), by striking “Not later than one year after the date of the enactment of this subsection, the Secretary” and inserting “The Secretary”;

36. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 228(2) · 121 Stat. 823

    1. Substituted · 21 U.S.C. § 374(g)(2)

       Pub. L. 110–85, § 228(2), substituted “The Secretary” for “Not later than 180 days after October 26, 2002, the Secretary”

    2. Struck · 21 U.S.C. § 374(g)(2)

       Pub. L. 110–85, § 228(2), struck out at end “In the first year following the publication in the Federal Register of criteria to accredit or deny accreditation to persons who request to perform the duties specified in paragraph (1), the Secretary shall accredit no more than 15 persons who request to perform duties specified in paragraph (1).”

    Source evidence

    Code amendment note
    Subsec. (g)(2). Pub. L. 110–85, § 228(2), substituted “The Secretary” for “Not later than 180 days after October 26, 2002, the Secretary” and struck out at end “In the first year following the publication in the Federal Register of criteria to accredit or deny accreditation to persons who request to perform the duties specified in paragraph (1), the Secretary shall accredit no more than 15 persons who request to perform duties specified in paragraph (1).”

    Enacted provision · exact public law section
    (2) in paragraph (2), by— (A) striking “Not later than 180 days after the date of enactment of this subsection, the Secretary” and inserting “The Secretary”; and (B) striking the fifth sentence;

37. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 228(3) · 121 Stat. 823

    Added · 21 U.S.C. § 374(g)(3)(F); 21 U.S.C. § 374(g)(3)(G)

    Pub. L. 110–85, § 228(3), added subpars. (F) and (G)

    Source evidence

    Code amendment note
    Subsec. (g)(3)(F), (G). Pub. L. 110–85, § 228(3), added subpars. (F) and (G).

    Enacted provision · exact public law section
    (3) in paragraph (3), by adding at the end the following: “(F) Notification. Deadline. Such person shall notify the Secretary of any withdrawal, suspension, restriction, or expiration of certificate of conformance with the quality systems standard referred to in paragraph (7) for any device establishment that such person inspects under this subsection not later than 30 days after such withdrawal, suspension, restriction, or expiration. “(G) Such person may conduct audits to establish conformance with the quality systems standard referred to in paragraph (7).” ;

38. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 228(4) · 121 Stat. 823

    Amended · 21 U.S.C. § 374(g)(6)

    Pub. L. 110–85, § 228(4), amended par. (6) generally, revising and restating provisions of former subpars. (A) to (C)

    Source evidence

    Code amendment note
    Subsec. (g)(6). Pub. L. 110–85, § 228(4), amended par. (6) generally, revising and restating provisions of former subpars. (A) to (C).

    Enacted provision · exact public law section
    (4) by amending paragraph (6) to read as follows: “(6) (A) Subject to subparagraphs (B) and (C), a device establishment is eligible for inspection by persons accredited under paragraph (2) if the following conditions are met: “(i) The Secretary classified the results of the most recent inspection of the establishment as ‘no action indicated’ or ‘voluntary action indicated’. “(ii) With respect to inspections of the establishment to be conducted by an accredited person, the owner or operator of the establishment submits to the Secretary a notice that— “(I) provides the date of the last inspection of the establishment by the Secretary and the classification of that inspection; “(II) states the intention of the owner or operator to use an accredited person to conduct inspections of the establishment; “(III) identifies the particular accredited person the owner or operator intends to select to conduct such inspections; and “(IV) includes a certification that, with respect to the devices that are manufactured, prepared, propagated, compounded, or processed in the establishment— “(aa) at least 1 of such devices is marketed in the United States; and “(bb) at least 1 of such devices is marketed, or is intended to be marketed, in 1 or more foreign countries, 1 of which countries certifies, accredits, or otherwise recognizes the person accredited under paragraph (2) and identified under subclause (III) as a person authorized to conduct inspections of device establishments. “(B) (i) Deadline. Except with respect to the requirement of subparagraph (A)(i), a device establishment is deemed to have clearance to participate in the program and to use the accredited person identified in the notice under subparagraph (A)(ii) for inspections of the establishment unless the Secretary, not later than 30 days after receiving such notice, issues a response that— “(I) denies clearance to participate as provided under subparagraph (C); or “(II) makes a request under clause (ii). “(ii) The Secretary may request from the owner or operator of a device establishment in response to the notice under subparagraph (A)(ii) with respect to the establishment, or from the particular accredited person identified in such notice— “(I) compliance data for the establishment in accordance with clause (iii)(I); or “(II) information concerning the relationship between the owner or operator of the establishment and the accredited person identified in such notice in accordance with clause (iii)(II). The Deadline. owner or operator of the establishment, or such accredited person, as the case may be, shall respond to such a request not later than 60 days after receiving such request. “(iii) (I) The compliance data to be submitted by the owner or operator of a device establishment in response to a request under clause (ii)(I) are data describing whether the quality controls of the establishment have been sufficient for ensuring consistent compliance with current good manufacturing practice within the meaning of section 501(h) and with other applicable provisions of this Act. Such data shall include complete reports of inspectional findings regarding good manufacturing practice or other quality control audits that, during the preceding 2-year period, were conducted at the establishment by persons other than the owner or operator of the establishment, together with all other compliance data the Secretary deems necessary. Data under the preceding sentence shall demonstrate to the Secretary whether the establishment has facilitated consistent compliance by promptly correcting any compliance problems identified in such inspections. “(II) A request to an accredited person under clause (ii)(II) may not seek any information that is not required to be maintained by such person in records under subsection (f)(1). “(iv) Deadline. A device establishment is deemed to have clearance to participate in the program and to use the accredited person identified in the notice under subparagraph (A)(ii) for inspections of the establishment unless the Secretary, not later than 60 days after receiving the information requested under clause (ii), issues a response that denies clearance to participate as provided under subparagraph (C). “(C) (i) The Secretary may deny clearance to a device establishment if the Secretary has evidence that the certification under subparagraph (A)(ii)(IV) is untrue and the Secretary provides to the owner or operator of the establishment a statement summarizing such evidence. “(ii) The Secretary may deny clearance to a device establishment if the Secretary determines that the establishment has failed to demonstrate consistent compliance for purposes of subparagraph (B)(iii)(I) and the Secretary provides to the owner or operator of the establishment a statement of the reasons for such determination. “(iii) (I) The Secretary may reject the selection of the accredited person identified in the notice under subparagraph (A)(ii) if the Secretary provides to the owner or operator of the establishment a statement of the reasons for such rejection. Reasons for the rejection may include that the establishment or the accredited person, as the case may be, has failed to fully respond to the request, or that the Secretary has concerns regarding the relationship between the establishment and such accredited person. “(II) Notification. If the Secretary rejects the selection of an accredited person by the owner or operator of a device establishment, the owner or operator may make an additional selection of an accredited person by submitting to the Secretary a notice that identifies the additional selection. Applicability. Clauses (i) and (ii) of subparagraph (B), and subclause (I) of this clause, apply to the selection of an accredited person through a notice under the preceding sentence in the same manner and to the same extent as such provisions apply to a selection of an accredited person through a notice under subparagraph (A)(ii). “(iv) In the case of a device establishment that is denied clearance under clause (i) or (ii) or with respect to which the selection of the accredited person is rejected under clause (iii), the Secretary shall designate a person to review the statement of reasons, or statement summarizing such evidence, as the case may be, of the Secretary under such clause if, during the 30-day period beginning on the date on which the owner or operator of the establishment receives such statement, the owner or operator requests the review. The Deadline. review shall commence not later than 30 days after the owner or operator requests the review, unless the Secretary and the owner or operator otherwise agree.” ;

39. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 228(5)(A) · 121 Stat. 823

    1. Added · 21 U.S.C. § 374(g)(7)(A)

       Pub. L. 110–85, § 228(5)(A), added subpar. (A)

    2. Struck · 21 U.S.C. § 374(g)(7)(A)

       Pub. L. 110–85, § 228(5)(A), struck out former subpar. (A) which read as follows: “Persons accredited under paragraph (2) to conduct inspections shall record in writing their inspection observations and shall present the observations to the device establishment’s designated representative and describe each observation. Additionally, such accredited person shall prepare an inspection report (including for inspections classified as ‘no action indicated’) in a form and manner consistent with such reports prepared by employees and officials designated by the Secretary to conduct inspections.”

    Source evidence

    Code amendment note
    Subsec. (g)(7)(A). Pub. L. 110–85, § 228(5)(A), added subpar. (A) and struck out former subpar. (A) which read as follows: “Persons accredited under paragraph (2) to conduct inspections shall record in writing their inspection observations and shall present the observations to the device establishment’s designated representative and describe each observation. Additionally, such accredited person shall prepare an inspection report (including for inspections classified as ‘no action indicated’) in a form and manner consistent with such reports prepared by employees and officials designated by the Secretary to conduct inspections.”

    Enacted provision · exact public law section
    (A) in subparagraph (A), by striking “(A) Persons” and all that follows through the end and inserting the following: “(A) Records. Persons accredited under paragraph (2) to conduct inspections shall record in writing their inspection observations and shall present the observations to the device establishment’s designated representative and describe each observation. Additionally, Reports. such accredited person shall prepare an inspection report in a form and manner designated by the Secretary to conduct inspections, taking into consideration the goals of international harmonization of quality systems standards. Any official classification of the inspection shall be determined by the Secretary.”; and

40. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 228(5)(B) · 121 Stat. 823

    Added · 21 U.S.C. § 374(g)(7)(F)

    Pub. L. 110–85, § 228(5)(B), added subpar. (F)

    Source evidence

    Code amendment note
    Subsec. (g)(7)(F). Pub. L. 110–85, § 228(5)(B), added subpar. (F).

    Enacted provision · exact public law section
    (B) by adding at the end the following: “(F) Audits. For the purpose of setting risk-based inspectional priorities, the Secretary shall accept voluntary submissions of reports of audits assessing conformance with appropriate quality systems standards set by the International Organization for Standardization (ISO) and identified by the Secretary in public notice. If the owner or operator of an establishment elects to submit audit reports under this subparagraph, the owner or operator shall submit all such audit reports with respect to the establishment during the preceding 2-year periods.” ; and

41. 2007

    Medical Device User Fee Amendments of 2007

    Pub. L. 110–85 § 228(6) · 121 Stat. 823

    Substituted · 21 U.S.C. § 374(g)(10)(C)(iii)

    Pub. L. 110–85, § 228(6), substituted “base amount applicable” for “based amount applicable”

    Source evidence

    Code amendment note
    Subsec. (g)(10)(C)(iii). Pub. L. 110–85, § 228(6), substituted “base amount applicable” for “based amount applicable”.

    Enacted provision · exact public law section
    (6) in paragraph (10)(C)(iii), by striking “based” and inserting “base”.

42. 2009

    Family Smoking Prevention and Tobacco Control Act

    Pub. L. 111–31 § 103(i)(1)(C) · 123 Stat. 1776

    Substituted · 21 U.S.C. § 374(a)(1)

    Pub. L. 111–31, § 103(i)(1)(C), substituted “devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) of this title, section 360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco products” for “and devices and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) section 360i, or 360j(g) of this title, and data relating to other drugs or devices”

    Source evidence

    Code amendment note
    Subsec. (a)(1). Pub. L. 111–31, § 103(i)(1)(C), substituted “devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) of this title, section 360i of this title, section 360j(g) of this title, or subchapter IX and data relating to other drugs, devices, or tobacco products” for “and devices and subject to reporting and inspection under regulations lawfully issued pursuant to section 355(i) or (k) section 360i, or 360j(g) of this title, and data relating to other drugs or devices”.

    Enacted provision · exact public law section
    (C) by striking “and devices and subject to” and all that follows through “other drugs or devices” and inserting “devices, and tobacco products and subject to reporting and inspection under regulations lawfully issued pursuant to section 505 (i) or (k), section 519, section 520(g), or chapter IX and data relating to other drugs, devices, or tobacco products”;

43. 2009

    Family Smoking Prevention and Tobacco Control Act

    Pub. L. 111–31 § 103(i)(1)(B) · 123 Stat. 1776

    Substituted · 21 U.S.C. § 374(a)(1)

    Pub. L. 111–31, § 103(i)(1)(B), substituted “restricted devices, or tobacco products” for “or restricted devices” in two places

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 111–31, § 103(i)(1)(B), substituted “restricted devices, or tobacco products” for “or restricted devices” in two places.

    Enacted provision · exact public law section
    (B) by striking “or restricted devices” each place it appears and inserting “restricted devices, or tobacco products”; and

44. 2009

    Family Smoking Prevention and Tobacco Control Act

    Pub. L. 111–31 § 103(i)(1)(A) · 123 Stat. 1776

    Substituted · 21 U.S.C. § 374(a)(1)(A)

    Pub. L. 111–31, § 103(i)(1)(A), substituted “devices, tobacco products, or cosmetics” for “devices, or cosmetics” in two places

    Source evidence

    Code amendment note
    Subsec. (a)(1)(A). Pub. L. 111–31, § 103(i)(1)(A), substituted “devices, tobacco products, or cosmetics” for “devices, or cosmetics” in two places.

    Enacted provision · exact public law section
    (A) by striking “devices, or cosmetics” each place it appears and inserting “devices, tobacco products, or cosmetics”;

45. 2009

    Family Smoking Prevention and Tobacco Control Act

    Pub. L. 111–31 § 103(i)(2) · 123 Stat. 1776

    Inserted · 21 U.S.C. § 374(b)

    Pub. L. 111–31, § 103(i)(2), inserted “tobacco product,” after “device,”

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 111–31, § 103(i)(2), inserted “tobacco product,” after “device,”.

    Enacted provision · exact public law section
    (2) in subsection (b), by inserting “tobacco product,” after “device,”; and

46. 2009

    Family Smoking Prevention and Tobacco Control Act

    Pub. L. 111–31 § 103(i)(3) · 123 Stat. 1776

    Changed · 21 U.S.C. § 374(g)(13)

    Pub. L. 111–31, § 103(i)(3), made technical amendment to reference in original act which appears in text as reference to section 393(g) of this title

    Source evidence

    Code amendment note
    Subsec. (g)(13). Pub. L. 111–31, § 103(i)(3), made technical amendment to reference in original act which appears in text as reference to section 393(g) of this title.

    Enacted provision · exact public law section
    (3) in subsection (g)(13), by striking “section 903(g)” and inserting “section 1003(g)”.

47. 2011

    FDA Food Safety Modernization Act

    Pub. L. 111–353 title I § 101(b) · 124 Stat. 3885

    Substituted · 21 U.S.C. § 374(a)(1)

    Pub. L. 111–353, which directed the amendment of subsec. (a)(1)(B) by substituting “section 350c of this title, when the standard for records inspection under paragraph (1) or (2) of section 350c(a) of this title applies, subject to” for “section 350c of this title when” and all that follows through “subject to”, was executed by making the substitution for “section 350c of this title when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to” in the sentence following subpar. (B) of subsec. (a)(1), to reflect the probable intent of Congress

    Source evidence

    Code amendment note
    Subsec. (a)(1). Pub. L. 111–353, which directed the amendment of subsec. (a)(1)(B) by substituting “section 350c of this title, when the standard for records inspection under paragraph (1) or (2) of section 350c(a) of this title applies, subject to” for “section 350c of this title when” and all that follows through “subject to”, was executed by making the substitution for “section 350c of this title when the Secretary has a reasonable belief that an article of food is adulterated and presents a threat of serious adverse health consequences or death to humans or animals, subject to” in the sentence following subpar. (B) of subsec. (a)(1), to reflect the probable intent of Congress.

    Enacted provision · exact public law section
    (b) Conforming Amendment.— Section 704(a)(1)(B) (21 U.S.C. 374(a)(1)(B)) is amended by striking “section 414 when” and all that follows through “subject to” and inserting “section 414, when the standard for records inspection under paragraph (1) or (2) of section 414(a) applies, subject to”.

48. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 706 · 126 Stat. 993

    Added · 21 U.S.C. § 374(a)(4)

    Pub. L. 112–144, § 706, added par. (4)

    Source evidence

    Code amendment note
    Subsec. (a)(4). Pub. L. 112–144, § 706, added par. (4).

    Enacted provision · exact public law section
    SEC. 706. RECORDS FOR INSPECTION.   Section 704(a) (21 U.S.C. 374(a)) is amended by adding at the end the following: “(4) (A) Any records or other information that the Secretary may inspect under this section from a person that owns or operates an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug shall, upon the request of the Secretary, be provided to the Secretary by such person, in advance of or in lieu of an inspection, within a reasonable timeframe, within reasonable limits, and in a reasonable manner, and in either electronic or physical form, at the expense of such person. The Secretary’s request shall include a sufficient description of the records requested. “(B) Confirmation. Upon receipt of the records requested under subparagraph (A), the Secretary shall provide to the person confirmation of receipt. “(C) Nothing in this paragraph supplants the authority of the Secretary to conduct inspections otherwise permitted under this Act in order to ensure compliance with this Act.” .

49. 2012

    Food and Drug Administration Safety and Innovation Act

    Pub. L. 112–144 § 612 · 126 Stat. 993

    Substituted · 21 U.S.C. § 374(g)(11)

    Pub. L. 112–144, § 612, substituted “October 1, 2017” for “October 1, 2012”

    Source evidence

    Code amendment note
    Subsec. (g)(11). Pub. L. 112–144, § 612, substituted “October 1, 2017” for “October 1, 2012”.

    Enacted provision · exact public law section
    SEC. 612. REAUTHORIZATION OF THIRD-PARTY INSPECTION.   Section 704(g)(11) (21 U.S.C. 374(g)(11)) is amended by striking “October 1, 2012” and inserting “October 1, 2017”.

50. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 703 · 131 Stat. 1005

    Substituted · 21 U.S.C. § 374(g)(11)

    Pub. L. 115–52, § 703, substituted “October 1, 2022” for “October 1, 2017”

    Source evidence

    Code amendment note
    Subsec. (g)(11). Pub. L. 115–52, § 703, substituted “October 1, 2022” for “October 1, 2017”.

    Enacted provision · exact public law section
    SEC. 703. REAUTHORIZATION OF INSPECTION PROGRAM.   Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)(11)) is amended by striking “October 1, 2017” and inserting “October 1, 2022”.

51. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 705 · 131 Stat. 1005

    Added · 21 U.S.C. § 374(g)(15)

    Pub. L. 115–52, § 705, added par. (15)

    Source evidence

    Code amendment note
    Subsec. (g)(15). Pub. L. 115–52, § 705, added par. (15).

    Enacted provision · exact public law section
    SEC. 705. FACILITATING INTERNATIONAL HARMONIZATION.   Section 704(g) of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 374) is amended by adding at the end the following: “(15) (A) Notwithstanding any other provision of this subsection, the Secretary may recognize auditing organizations that are recognized by organizations established by governments to facilitate international harmonization for purposes of conducting inspections of— “(i) establishments that manufacture, prepare, propagate, compound, or process devices (other than types of devices licensed under section 351 of the Public Health Service Act), as required under section 510(h); or “(ii) establishments required to register pursuant to section 510(i). “(B) Nothing in this paragraph affects— “(i) the authority of the Secretary to inspect any device establishment pursuant to this Act; or “(ii) the authority of the Secretary to determine the official classification of an inspection.” .

52. 2017

    FDA Reauthorization Act of 2017

    Pub. L. 115–52 § 702(a) · 131 Stat. 1005

    Added · 21 U.S.C. § 374(h)

    Pub. L. 115–52, § 702(a), added subsec. (h)

    Source evidence

    Code amendment note
    Subsec. (h). Pub. L. 115–52, § 702(a), added subsec. (h).

    Enacted provision · exact public law section
    (a) In General.— Section 704 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374) is amended by adding at the end the following: “(h) (1) In the case of inspections other than for-cause inspections, the Secretary shall review processes and standards applicable to inspections of domestic and foreign device establishments in effect as of the date of the enactment of this subsection, and update such processes and standards through the adoption of uniform processes and standards applicable to such inspections. Such uniform processes and standards shall provide for— “(A) exceptions to such processes and standards, as appropriate; “(B) announcing the inspection of the establishment within a reasonable time before such inspection occurs, including by providing to the owner, operator, or agent in charge of the establishment a notification regarding the type and nature of the inspection; “(C) a reasonable estimate of the timeframe for the inspection, an opportunity for advance communications between the officers or employees carrying out the inspection under subsection (a)(1) and the owner, operator, or agent in charge of the establishment concerning appropriate working hours during the inspection, and, to the extent feasible, advance notice of some records that will be requested; and “(D) regular communications during the inspection with the owner, operator, or agent in charge of the establishment regarding inspection status, which may be recorded by either party with advance notice and mutual consent. “(2) (A) The Secretary shall, with respect to a request described in subparagraph (B), provide nonbinding feedback with respect to such request not later than 45 days after the Secretary receives such request. “(B) A request described in this subparagraph is a request for feedback— “(i) that is made by the owner, operator, or agent in charge of such establishment in a timely manner; and “(ii) with respect to actions proposed to be taken by a device establishment in a response to a report received by such establishment pursuant to subsection (b) that involve a public health priority, that implicate systemic or major actions, or relate to emerging safety issues (as determined by the Secretary). “(3) Nothing in this subsection affects the authority of the Secretary to conduct inspections otherwise permitted under this Act in order to ensure compliance with this Act.” .

53. 2020

    Coronavirus Aid, Relief, and Economic Security Act

    Pub. L. 116–136 § 3112(d)(1) · 134 Stat. 281

    1. Amended · 21 U.S.C. § 374(b)

       Pub. L. 116–136, § 3112(d)(1), as amended by Pub. L. 117–328, § 2515(a)(2)

    2. Amended · 21 U.S.C. § 374(b)

       Pub. L. 116–136, § 3112(d)(1), as designated existing provisions as par. (1)

    3. Redesignated · 21 U.S.C. § 374(b)

       Pub. L. 116–136, § 3112(d)(1), as redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, of par. (1)

    4. Added · 21 U.S.C. § 374(b)

       Pub. L. 116–136, § 3112(d)(1), as added par. (2)

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 116–136, § 3112(d)(1), as amended by Pub. L. 117–328, § 2515(a)(2), designated existing provisions as par. (1), redesignated former pars. (1) and (2) as subpars. (A) and (B), respectively, of par. (1), and added par. (2).

    Enacted provision · exact public law section
    (1) by redesignating paragraphs (1) and (2) and subparagraphs (A) and (B);

    Effective date note
    Amendment by Pub. L. 116–136 effective 180 days after Mar. 27, 2020, see section 3112(g) of Pub. L. 116–136, set out as a note under section 356c of this title.

54. 2022

    FDA User Fee Reauthorization Act of 2022

    Pub. L. 117–180 div. F title V § 5007 · 136 Stat. 2114

    Substituted · 21 U.S.C. § 374(g)(11)

    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. 5007. REAUTHORIZATION OF CERTAIN DEVICE INSPECTIONS.   Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)(11)) is amended by striking “October 1” and inserting “December 17”.

55. 2022

    Further Continuing Appropriations and Extensions Act, 2023

    Pub. L. 117–229 div. C title III § 306 · 136 Stat. 2308

    Substituted · 21 U.S.C. § 374(g)(11)

    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. 306. REAUTHORIZATION OF CERTAIN DEVICE INSPECTIONS.   Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)(11)) is amended by striking “December 17, 2022” and inserting “December 24, 2022”.

56. 2022

    Food and Drug Omnibus Reform Act of 2022

    Pub. L. 117–328 § 3611(a) · 136 Stat. 4459

    Substituted · 21 U.S.C. § 374(a)(1)

    Pub. L. 117–328, § 3611(a), substituted “devices” for “restricted devices” in two places

    Source evidence

    Code amendment note
    Subsec. (a)(1). Pub. L. 117–328, § 3611(a), substituted “devices” for “restricted devices” in two places.

    Enacted provision · exact public law section
    (a) In General.— Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by striking “restricted devices” each place it appears and inserting “devices”.

57. 2022

    Modernization of Cosmetics Regulation Act of 2022

    Pub. L. 117–328 § 3504 · 136 Stat. 4459

    Inserted · 21 U.S.C. § 374(a)(1)

    Pub. L. 117–328, § 3504, inserted “In the case of a facility (as defined in section 364 of this title) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 364a, 364b, and 364f of this title, when the standard for records inspection under such section applies.” after “limitations established in section 350c(d) of this title.”

    Target inherited from the preceding amendment note.

    Source evidence

    Code amendment note
    Pub. L. 117–328, § 3504, inserted “In the case of a facility (as defined in section 364 of this title) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 364a, 364b, and 364f of this title, when the standard for records inspection under such section applies.” after “limitations established in section 350c(d) of this title.”

    Enacted provision · exact public law section
    SEC. 3504. RECORDS INSPECTION.   Section 704(a)(1) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(1)) is amended by inserting after the second sentence the following: “In the case of a facility (as defined in section 604) that manufactures or processes cosmetic products, the inspection shall extend to all records and other information described in sections 605, 606, and 610, when the standard for records inspection under such section applies.”.

58. 2022

    Food and Drug Omnibus Reform Act of 2022

    Pub. L. 117–328 § 3611(b)(1) · 136 Stat. 4459

    1. Substituted · 21 U.S.C. § 374(a)(4)(A)

       Pub. L. 117–328, § 3611(b)(1), substituted “an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under paragraph (5)(C),” for “an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug”

    2. Substituted · 21 U.S.C. § 374(a)(4)(A)

       Pub. L. 117–328, § 3611(b)(1), substituted “records or other information requested and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection.” for “records requested.”

    Source evidence

    Code amendment note
    Subsec. (a)(4)(A). Pub. L. 117–328, § 3611(b)(1), substituted “an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under paragraph (5)(C),” for “an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug” and “records or other information requested and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection.” for “records requested.”

    Enacted provision · exact public law section
    (1) Establishments.— Section 704(a)(4)(A) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)(A)) is amended— (A) by striking “an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug” and inserting “an establishment that is engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or device, or a site or facility that is subject to inspection under paragraph (5)(C),”; and (B) by striking “records requested.” and inserting the following: “records or other information requested and a rationale for requesting such records or other information in advance of, or in lieu of, an inspection.”.

59. 2022

    Food and Drug Omnibus Reform Act of 2022

    Pub. L. 117–328 § 3613(b) · 136 Stat. 4459

    1. Added · 21 U.S.C. § 374(a)(4)(C); 21 U.S.C. § 374(a)(4)(D)

       Pub. L. 117–328, § 3613(b), added subpar. (C)

    2. Redesignated · 21 U.S.C. § 374(a)(4)(C); 21 U.S.C. § 374(a)(4)(D)

       Pub. L. 117–328, § 3613(b), redesignated former subpar. (C) as (D)

    Source evidence

    Code amendment note
    Subsec. (a)(4)(C), (D). Pub. L. 117–328, § 3613(b), added subpar. (C) and redesignated former subpar. (C) as (D).

    Enacted provision · exact public law section
    (b) Use of Records.— Section 704(a)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)(4)) is amended— (1) by redesignating subparagraph (C) as subparagraph (D); and (2) by inserting after subparagraph (B) the following: “(C) The Secretary may rely on any records or other information that the Secretary may inspect under this section to satisfy requirements that may pertain to a preapproval or risk-based surveillance inspection, or to resolve deficiencies identified during such inspections, if applicable and appropriate.” .

60. 2022

    Food and Drug Omnibus Reform Act of 2022

    Pub. L. 117–328 § 3612(a) · 136 Stat. 4459

    Added · 21 U.S.C. § 374(a)(5)

    Pub. L. 117–328, § 3612(a), added par. (5)

    Source evidence

    Code amendment note
    Subsec. (a)(5). Pub. L. 117–328, § 3612(a), added par. (5).

    Enacted provision · exact public law section
    (a) In General.— Section 704(a) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(a)) is amended by adding at the end the following: “(5) (A) The Secretary may, to ensure the accuracy and reliability of studies and records or other information described in subparagraph (B) and to assess compliance with applicable requirements under this Act or the Public Health Service Act, enter sites and facilities specified in subparagraph (C) in order to inspect such records or other information. “(B) An inspection under this paragraph shall extend to all records and other information related to the studies and submissions described in subparagraph (E), including records and information related to the conduct, results, and analyses of, and the protection of human and animal trial participants participating in, such studies. “(C) (i) The sites and facilities subject to inspection by the Secretary under this paragraph are those owned or operated by a person described in clause (ii) and which are (or were) utilized by such person in connection with— “(I) developing an application or other submission to the Secretary under this Act or the Public Health Service Act related to marketing authorization for a product described in paragraph (1); “(II) preparing, conducting, or analyzing the results of a study described in subparagraph (E); or “(III) holding any records or other information described in subparagraph (B). “(ii) A person described in this clause is— “(I) the sponsor of an application or submission specified in subparagraph (E); “(II) a person engaged in any activity described in clause (i) on behalf of such a sponsor, through a contract, grant, or other business arrangement with such sponsor; “(III) an institutional review board, or other individual or entity, engaged by contract, grant, or other business arrangement with a nonsponsor in preparing, collecting, or analyzing records or other information described in subparagraph (B); or “(IV) any person not otherwise described in this clause that conducts, or has conducted, a study described in subparagraph (E) yielding records or other information described in subparagraph (B). “(D) (i) Subject to clause (ii), an entity that owns or operates any site or facility subject to inspection under this paragraph shall provide the Secretary with access to records and other information described in subparagraph (B) that is held by or under the control of such entity, including— “(I) permitting the Secretary to record or copy such information for purposes of this paragraph; “(II) providing the Secretary with access to any electronic information system utilized by such entity to hold, process, analyze, or transfer any records or other information described in subparagraph (B); and “(III) permitting the Secretary to inspect the facilities, equipment, written procedures, processes, and conditions through which records or other information described in subparagraph (B) is or was generated, held, processed, analyzed, or transferred. “(ii) Nothing in clause (i) shall negate, supersede, or otherwise affect the applicability of provisions, under this or any other Act, preventing or limiting the disclosure of confidential commercial information or other information considered proprietary or trade secret. “(iii) An inspection under this paragraph shall be conducted at reasonable times and within reasonable limits and in a reasonable manner. “(E) The studies and submissions described in this subparagraph are each of the following: “(i) Clinical and nonclinical studies submitted to the Secretary in support of, or otherwise related to, applications and other submissions to the Secretary under this Act or the Public Health Service Act for marketing authorization of a product described in paragraph (1). Studies. “(ii) Postmarket safety activities conducted under this Act or the Public Health Service Act. “(iii) Any other clinical investigation of— “(I) a drug subject to section 505 or 512 of this Act or section 351 of the Public Health Service Act; or “(II) a device subject to section 520(g). “(iv) Any other submissions made under this Act or the Public Health Service Act with respect to which the Secretary determines an inspection under this paragraph is warranted in the interest of public health. “(F) This paragraph clarifies the authority of the Secretary to conduct inspections of the type described in this paragraph and shall not be construed as a basis for inferring that, prior to the date of enactment of this paragraph, the Secretary lacked the authority to conduct such inspections, including under this Act or the Public Health Service Act.” .

61. 2022

    Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act

    Pub. L. 117–328 § 2515(a)(2) · 136 Stat. 4459

    Changed · 21 U.S.C. § 374(b)

    Pub. L. 117–328, § 2515(a)(2), made technical amendment to directory language of Pub. L. 116–136, § 3112(d)(1). See 2020 Amendment note below

    Source evidence

    Code amendment note
    Subsec. (b). Pub. L. 117–328, § 2515(a)(2), made technical amendment to directory language of Pub. L. 116–136, § 3112(d)(1). See 2020 Amendment note below.

    Enacted provision · exact public law section
    (2) in section 3112(d)(1), 21 USC 374. by striking “and subparagraphs (A) and (B)” and inserting “as subparagraphs (A) and (B)”; and

62. 2022

    Food and Drug Omnibus Reform Act of 2022

    Pub. L. 117–328 § 3106 · 136 Stat. 4459

    Substituted · 21 U.S.C. § 374(g)(11)

    Pub. L. 117–328, § 3106, substituted “October 1, 2027” for “December 24, 2022”

    Source evidence

    Code amendment note
    Subsec. (g)(11). Pub. L. 117–328, § 3106, substituted “October 1, 2027” for “December 24, 2022”.

    Enacted provision · exact public law section
    SEC. 3106. REAUTHORIZATION OF CERTAIN DEVICE INSPECTIONS.   Section 704(g)(11) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 374(g)(11)) is amended by striking “December 24, 2022” and inserting “October 1, 2027”.

79 of 79 references resolved to an enrolled provision