2004—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.”

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.”

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”.

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.

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

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.

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.”

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”.

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”.

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”.

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”.

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

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”.

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

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;”.

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;”.

2002—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.”

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

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”.

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”.

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

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

1997—Subsec. (a)(1). Pub. L. 105–115, § 412(b), substituted “prescription drugs, nonprescription drugs intended for human use,” for “prescription drugs” in two places.

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

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

1993—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)”.

1980—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.

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.

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

1976—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.

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

1962—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”.

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

1953—Act Aug. 7, 1953, designated existing provisions as subsec. (a) and amended them by substituting provisions permitting entry and inspection upon presentation of appropriate credentials and a written notice to the owner, operator, or agent in charge for provisions which authorized entry and inspection only after making a request and obtaining permission from the owner, operator, or custodian, and inserting provisions requiring a separate written notice for each inspection but not for each entry made during the period covered by the inspection, and directing that the inspection shall be conducted within reasonable limits, in a reasonable manner and completed with reasonable promptness, and added subsecs. (b) to (d).

Amendment by sections 210(b) and 412(b) of Pub. L. 105–115 effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as a note under section 321 of this title.

Amendment by Pub. L. 87–781 effective Oct. 10, 1962, see section 203 of Pub. L. 87–781, set out as a note under section 332 of this title.

For transfer of functions of Federal Security Administrator to Secretary of Health, Education, and Welfare [now Health and Human Services], and of Food and Drug Administration in the Department of Agriculture to Federal Security Agency, see notes set out under section 321 of this title.

Section 201(d) of Pub. L. 87–781 provided that: “Nothing in the amendments made by subsections (a) and (b) of this section [amending this section] shall be construed to negate or derogate from any authority of the Secretary existing prior to the enactment of this Act [Oct. 10, 1962].”