Source: https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360&num=0&edition=prelim
Timestamp: 2020-01-17 16:54:33
Document Index: 116917631

Matched Legal Cases: ['§ 360', '§510', '§302', '§4', '§701', '§3', '§4', '§125', '§206', '§417', '§321', '§201', '§302', '§2', '§222', '§801', '§604', '§701', '§3054', '§701', '§901', '§701', '§701', '§701', '§901', '§5', '§3059', '§2', '§301', '§303']

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21 USC 360: Registration of producers of drugs or devices Text contains those laws in effect on January 16, 2020
(2) Risk-based schedule for devices
The Secretary, acting through one or more officers or employees duly designated by the Secretary, shall inspect establishments described in paragraph (1) that are engaged in the manufacture, propagation, compounding, or processing of a device or devices (referred to in this subsection as "device establishments") in accordance with a risk-based schedule established by the Secretary.
(B) Factors and considerations
In establishing the risk-based schedule under subparagraph (A), the Secretary shall-
(i) apply, to the extent applicable for device establishments, the factors identified in paragraph (4); and
(ii) consider the participation of the device establishment, as applicable, in international device audit programs in which the United States participates or the United States recognizes for purposes of inspecting device establishments.
In establishing a risk-based schedule under paragraph (2) or (3), the Secretary shall inspect establishments according to the known safety risks of such establishments, which shall be based on the following factors:
(C) The inherent risk of the drug or device manufactured, prepared, propagated, compounded, or processed at the establishment.
Beginning in 2014, not later than May 1 of each year, the Secretary shall make available on the Internet Web site of the Food and Drug Administration a report regarding-
(June 25, 1938, ch. 675, §510, as added Pub. L. 87–781, title III, §302, Oct. 10, 1962, 76 Stat. 794 ; amended Pub. L. 89–74, §4, July 15, 1965, 79 Stat. 231 ; Pub. L. 91–513, title II, §701(e), Oct. 27, 1970, 84 Stat. 1282 ; Pub. L. 92–387, §§3, 4(a)–(c), Aug. 16, 1972, 86 Stat. 560–562 ; Pub. L. 94–295, §4(a), May 28, 1976, 90 Stat. 579 ; Pub. L. 105–115, title I, §125(a)(2)(C), title II, §§206(a), 209(a), 213(b), title IV, §417, Nov. 21, 1997, 111 Stat. 2325 , 2338, 2341, 2347, 2379; Pub. L. 107–188, title III, §321(a), June 12, 2002, 116 Stat. 675 ; Pub. L. 107–250, title II, §§201(e), 207, 211, title III, §302(b), Oct. 26, 2002, 116 Stat. 1609 , 1613, 1614, 1616; Pub. L. 108–214, §2(c)(2), Apr. 1, 2004, 118 Stat. 576 ; Pub. L. 110–85, title II, §§222–224, title VIII, §801(b)(3)(C), Sept. 27, 2007, 121 Stat. 853 , 921; Pub. L. 112–144, title VI, §604, title VII, §§701, 702(b)–705, July 9, 2012, 126 Stat. 1052 , 1064-1066; Pub. L. 114–255, div. A, title III, §§3054, 3059(a), 3101(a)(2)(H), Dec. 13, 2016, 130 Stat. 1126 , 1130, 1154; Pub. L. 115–52, title VII, §701(a), title IX, §901(e), Aug. 18, 2017, 131 Stat. 1054 , 1076.)
2017-Subsec. (h)(2). Pub. L. 115–52, §701(a)(1), added par. (2) and struck out former par. (2). Prior to amendment, text read as follows: "Every establishment described in paragraph (1), in any State, that is engaged in the manufacture, propagation, compounding, or processing of a device or devices classified in class II or III shall be so inspected by one or more officers or employees duly designated by the Secretary, or by persons accredited to conduct inspections under section 374(g) of this title, at least once in the 2-year period beginning with the date of registration of such establishment pursuant to this section and at least once in every successive 2-year period thereafter."
Subsec. (h)(4). Pub. L. 115–52, §701(a)(2)(A), substituted "paragraph (2) or (3)" for "paragraph (3)" in introductory provisions.
Subsec. (h)(4)(C). Pub. L. 115–52, §701(a)(2)(B), inserted "or device" after "drug".
Subsec. (h)(6). Pub. L. 115–52, §901(e), substituted "May 1" for "February 1" in introductory provisions.
Pub. L. 92–387, §5, Aug. 16, 1972, 86 Stat. 562 , provided that: "The amendments made by this Act [amending this section and sections 331 and 335 of this title and enacting provisions set out below] shall take effect on the first day of the sixth month beginning after the date of enactment of this Act [Aug. 16, 1972]."
Pub. L. 114–255, div. A, title III, §3059(b), Dec. 13, 2016, 130 Stat. 1130 , provided that: "The Secretary of Health and Human Services, acting through the Commissioner of Food and Drugs, shall issue final guidance regarding when a premarket notification under section 510(k) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k)) is required to be submitted for a modification or change to a legally marketed device. Such final guidance shall be issued not later than 1 year after the date on which the comment period closes for the draft guidance on such subject."
Pub. L. 92–387, §2, Aug. 16, 1972, 86 Stat. 559 , provided that: "The Federal Government which is responsible for regulating drugs has no ready means of determining what drugs are actually being manufactured or packed by establishments registered under the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 301 et seq.] except by periodic inspection of such registered establishments. Knowledge of which particular drugs are being manufactured or packed by each registered establishment would substantially assist in the enforcement of Federal laws requiring that such drugs be pure, safe, effective, and properly labeled. Information on the discontinuance of a particular drug could serve to alleviate the burden of reviewing and implementing enforcement actions against drugs which, although commercially discontinued, remain active for regulatory purposes. Information on the type and number of different drugs being manufactured or packed by drug establishments could permit more effective and timely regulation by the agencies of the Federal Government responsible for regulating drugs, including identification of which drugs in interstate commerce are subject to section 505 or 507 [21 U.S.C. 355, 357], or to other provisions of the Federal Food, Drug, and Cosmetic Act."
Pub. L. 87–781, title III, §301, Oct. 10, 1962, 76 Stat. 793 , provided that: "The Congress hereby finds and declares that in order to make regulation of interstate commerce in drugs effective, it is necessary to provide for registration and inspection of all establishments in which drugs are manufactured, prepared, propagated, compounded, or processed; that the products of all such establishments are likely to enter the channels of interstate commerce and directly affect such commerce; and that the regulation of interstate commerce in drugs without provision for registration and inspection of establishments that may be engaged only in intrastate commerce in such drugs would discriminate against and depress interstate commerce in such drugs, and adversely burden, obstruct, and affect such interstate commerce."
Pub. L. 87–781, title III, §303, Oct. 10, 1962, 76 Stat. 795 , provided that any person who, on the day immediately preceding Oct. 10, 1962, owned or operated an establishment which manufactured or processed drugs, registered before the first day of the seventh month following October, 1962, would be deemed to be registered in accordance with subsec. (b) of this section for the calendar year 1962 and if registered within this period and effected in 1963, be deemed in compliance for that calendar year.