dreamproit/uscode huggingface dataset:
21 U.S.C. § 359 (FOOD AND DRUGS)
§ 359. Nonapplicability of subchapter to cosmetics
This subchapter, as amended by the Drug Amendments of 1962, shall not apply to any cosmetic unless such cosmetic is also a drug or device or component thereof.
(June 25, 1938, ch. 675, § 509, as added Pub. L. 87–781, title I, § 113, Oct. 10, 1962, 76 Stat. 791.)
heading: Editorial Notes
heading: References in Text
text: This subchapter, as amended by the Drug Amendments of 1962, referred to in text, means the amendment of this subchapter by Pub. L. 87–781 which enacted sections 358 to 360 of this title, amended sections 351 to 353, 355, and 357 of this title, and enacted provisions set out as notes under sections 352, 355, 358, and 360 of this title.
The Drug Amendments of 1962, referred to in text, is Pub. L. 87–781, Oct. 10, 1962, 76 Stat. 780, as amended. For complete classification of this Act to the Code, see Short Title of 1962 Amendment note set out under section 301 of this title and Tables.
21 U.S.C. § 360a (FOOD AND DRUGS)
§ 360a. Clinical trial guidance for antibiotic drugs
(a) In general
Not later than 1 year after September 27, 2007, the Secretary shall issue guidance for the conduct of clinical trials with respect to antibiotic drugs, including antimicrobials to treat acute bacterial sinusitis, acute bacterial otitis media, and acute bacterial exacerbation of chronic bronchitis. Such guidance shall indicate the appropriate models and valid surrogate markers.
(b) Review
Not later than 5 years after September 27, 2007, the Secretary shall review and update the guidance described under subsection (a) to reflect developments in scientific and medical information and technology.
(June 25, 1938, ch. 675, § 511, as added Pub. L. 110–85, title IX, § 911, Sept. 27, 2007, 121 Stat. 951.)
heading: Editorial Notes
heading: Prior Provisions
text: A prior section 360a, act June 25, 1938, ch. 675, § 511, as added July 15, 1965, Pub. L. 89–74, § 3(b), 79 Stat. 227; amended Oct. 24, 1968, Pub. L. 90–639, § 2(a), 82 Stat. 1361, regulated the manufacture, compounding, and processing of depressant and stimulant drugs and their sale, delivery, disposal, possession, and recordkeeping activities connected therewith, prior to repeal by Pub. L. 91–513, title II, §§ 701(a), 704, Oct. 27, 1970, 84 Stat. 1281, 1284, effective on the first day of the seventh calendar month that began after Oct. 26, 1970.
21 U.S.C. § 360c–1 (FOOD AND DRUGS)
§ 360c–1. Reporting
The Secretary of Health and Human Services shall annually post on the Internet Web site of the Food and Drug Administration—
(1) the number and type of class I and class II devices reclassified as class II or class III in the previous calendar year under section 360c(e)(1) of this title;
(2) the number and type of class II and class III devices reclassified as class I or class II in the previous calendar year under such section 360c(e)(1) of this title; and
(3) the number and type of devices reclassified in the previous calendar year under section 360e of this title.
(Pub. L. 112–144, title VI, § 608(c), July 9, 2012, 126 Stat. 1059.)
heading: Editorial Notes
heading: Codification
text: Section was enacted as part of the Food and Drug Administration Safety and Innovation Act, and not as part of the Federal Food, Drug, and Cosmetic Act which comprises this chapter.
21 U.S.C. § 360f (FOOD AND DRUGS)
§ 360f. Banned devices
(a) General rule
Whenever the Secretary finds, on the basis of all available data and information, that—
(1) a device intended for human use presents substantial deception or an unreasonable and substantial risk of illness or injury; and
(2) in the case of substantial deception or an unreasonable and substantial risk of illness or injury which the Secretary determined could be corrected or eliminated by labeling or change in labeling and with respect to which the Secretary provided written notice to the manufacturer specifying the deception or risk of illness or injury, the labeling or change in labeling to correct the deception or eliminate or reduce such risk, and the period within which such labeling or change in labeling was to be done, such labeling or change in labeling was not done within such period;
he may initiate a proceeding to promulgate a regulation to make such device a banned device.
(b) Special effective date
The Secretary may declare a proposed regulation under subsection (a) to be effective upon its publication in the Federal Register and until the effective date of any final action taken respecting such regulation if (1) he determines, on the basis of all available data and information, that the deception or risk of illness or injury associated with the use of the device which is subject to the regulation presents an unreasonable, direct, and substantial danger to the health of individuals, and (2) before the date of the publication of such regulation, the Secretary notifies the manufacturer of such device that such regulation is to be made so effective. If the Secretary makes a proposed regulation so effective, he shall, as expeditiously as possible, give interested persons prompt notice of his action under this subsection, provide reasonable opportunity for an informal hearing on the proposed regulation, and either affirm, modify, or revoke such proposed regulation.
(June 25, 1938, ch. 675, § 516, as added Pub. L. 94–295, § 2, May 28, 1976, 90 Stat. 560; amended Pub. L. 101–629, § 18(d), Nov. 28, 1990, 104 Stat. 4529.)
heading: Editorial Notes
heading: Amendments
text: 1990—Subsec. (a). Pub. L. 101–629 struck out “and after consultation with the appropriate panel or panels under section 360c of this title” after “data and information” in introductory provisions and struck out at end “The Secretary shall afford all interested persons opportunity for an informal hearing on a regulation proposed under this subsection.”
21 U.S.C. § 360g–1 (FOOD AND DRUGS)
§ 360g–1. Agency documentation and review of significant decisions regarding devices
(a) Documentation of rationale for significant decisions
(1) In general
The Secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding submission or review of a report under section 360(k) of this title, an application under section 360e of this title, a request for designation under section 360e–3 of this title, or an application for an exemption under section 360j(g) of this title, including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion.
(2) Provision of documentation
Upon request, the Secretary shall furnish such substantive summary to the person who is seeking to submit, or who has submitted, such report or application.
(3) Application of least burdensome requirements
The substantive summary required under this subsection shall include a brief statement regarding how the least burdensome requirements were considered and applied consistent with section 360c(i)(1)(D) of this title, section 360c(a)(3)(D) of this title, and section 360e(c)(5) of this title, as applicable.
(b) Review of significant decisions
(1) Request for supervisory review of significant decision
Any person may request a supervisory review of the significant decision described in subsection (a)(1). Such review may be conducted at the next supervisory level or higher above the individual who made the significant decision.
(2) Submission of request
A person requesting a supervisory review under paragraph (1) shall submit such request to the Secretary not later than 30 days after such decision and shall indicate in the request whether such person seeks an in-person meeting or a teleconference review.
(3) Timeframe
(A) In general
Except as provided in subparagraph (B), the Secretary shall schedule an in-person or teleconference review, if so requested, not later than 30 days after such request is made. The Secretary shall issue a decision to the person requesting a review under this subsection not later than 45 days after the request is made under paragraph (1), or, in the case of a person who requests an in-person meeting or teleconference, 30 days after such meeting or teleconference.
(B) Exception
Subparagraph (A) shall not apply in cases that are referred to experts outside of the Food and Drug Administration.
(June 25, 1938, ch. 675, § 517A, as added Pub. L. 112–144, title VI, § 603, July 9, 2012, 126 Stat. 1051; amended Pub. L. 114–255, div. A, title III, §§ 3051(b), 3058(c), Dec. 13, 2016, 130 Stat. 1124, 1129.)
heading: Editorial Notes
heading: Amendments
text: 2016—Subsec. (a)(1). Pub. L. 114–255, § 3051(b), inserted “a request for designation under section 360e–3 of this title,” after “application under section 360e of this title,”.
Subsec. (a)(3). Pub. L. 114–255, § 3058(c), added par. (3).
21 U.S.C. § 360h–1 (FOOD AND DRUGS)
§ 360h–1. Program to improve the device recall system
(a) In general
The Secretary shall—
(1) establish a program to routinely and systematically assess information relating to device recalls and use such information to proactively identify strategies for mitigating health risks presented by defective or unsafe devices;
(2) clarify procedures for conducting device recall audit checks to improve the ability of investigators to perform those checks in a consistent manner;
(3) develop detailed criteria for assessing whether a person performing a device recall has performed an effective correction or action plan for the recall; and
(4) document the basis for each termination by the Food and Drug Administration of a device recall.
(b) Assessment content
The program established under subsection (a)(1) shall, at a minimum, identify—
(1) trends in the number and types of device recalls;
(2) devices that are most frequently the subject of a recall; and
(3) underlying causes of device recalls.
(c) Definition
In this section, the term “recall” means—
(1) the removal from the market of a device pursuant to an order of the Secretary under subsection (b) or (e) of section 360h of this title; or
(2) the correction or removal from the market of a device at the initiative of the manufacturer or importer of the device that is required to be reported to the Secretary under section 360i(g) of this title.
(June 25, 1938, ch. 675, § 518A, as added Pub. L. 112–144, title VI, § 605, July 9, 2012, 126 Stat. 1053; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(K), Dec. 13, 2016, 130 Stat. 1154.)
heading: Editorial Notes
heading: Amendments
text: 2016—Subsecs. (c), (d). Pub. L. 114–255 redesignated subsec. (d) as (c) and struck out former subsec. (c). Prior to amendment, text read as follows: “The Secretary shall document the basis for the termination by the Food and Drug Administration of a device recall.”
21 U.S.C. § 360n–1 (FOOD AND DRUGS)
§ 360n–1. Priority review for qualified infectious disease products
(a) In general
If the Secretary designates a drug under section 355f(d) of this title as a qualified infectious disease product, then the Secretary shall give priority review to the first application submitted for approval for such drug under section 355(b) of this title.
(b) Construction
Nothing in this section shall prohibit the Secretary from giving priority review to a human drug application or efficacy supplement submitted for approval under section 355(b) of this title that otherwise meets the criteria for the Secretary to grant priority review.
(June 25, 1938, ch. 675, § 524A, as added Pub. L. 112–144, title VIII, § 802(a), July 9, 2012, 126 Stat. 1079; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(N), Dec. 13, 2016, 130 Stat. 1154.)
heading: Editorial Notes
heading: Amendments
text: 2016—Pub. L. 114–255 designated existing provisions as subsec. (a), inserted heading, substituted “the first application” for “any application”, and added subsec. (b).
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date
text: Pub. L. 112–144, title VIII, § 802(b), July 9, 2012, 126 Stat. 1079, provided that: “Section 524A of the Federal Food, Drug, and Cosmetic Act [21 U.S.C. 360n–1], as added by subsection (a), applies only with respect to an application that is submitted under section 505(b) of such Act (21 U.S.C. 355(b)) on or after the date of the enactment of this Act [July 9, 2012].”
21 U.S.C. § 360rr (FOOD AND DRUGS)
§ 360rr. Federal-State cooperation
The Secretary is authorized (1) to accept from State and local authorities engaged in activities related to health or safety or consumer protection, on a reimbursable basis or otherwise, any assistance in the administration and enforcement of this part which he may request and which they may be able and willing to provide and, if so agreed, may pay in advance or otherwise for the reasonable cost of such assistance, and (2) he may, for the purpose of conducting examinations, investigations, and inspections, commission any officer or employee of any such authority as an officer of the Department.
(June 25, 1938, ch. 675, § 541, formerly act July 1, 1944, ch. 373, title III, § 541, formerly § 360E, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered § 541 and amended Pub. L. 101–629, § 19(a)(1)(B), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.)
heading: Editorial Notes
heading: Codification
text: Section was classified to section 263m of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.
heading: Amendments
text: 1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, § 19(a)(4), which renumbered section 263m of Title 42, The Public Health and Welfare, as this section.
1990—Pub. L. 101–629, § 19(a)(1)(B), substituted “this part” for “this subpart”.
heading: Statutory Notes and Related Subsidiaries
heading: Noninterference With Other Federal Agencies
text: Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.
21 U.S.C. § 360ss (FOOD AND DRUGS)
§ 360ss. State standards
Whenever any standard prescribed pursuant to section 360kk of this title with respect to an aspect of performance of an electronic product is in effect, no State or political subdivision of a State shall have any authority either to establish, or to continue in effect, any standard which is applicable to the same aspect of performance of such product and which is not identical to the Federal standard. Nothing in this part shall be construed to prevent the Federal Government or the government of any State or political subdivision thereof from establishing a requirement with respect to emission of radiation from electronic products procured for its own use if such requirement imposes a more restrictive standard than that required to comply with the otherwise applicable Federal standard.
(June 25, 1938, ch. 675, § 542, formerly act July 1, 1944, ch. 373, title III, § 542, formerly § 360F, as added Pub. L. 90–602, § 2(3), Oct. 18, 1968, 82 Stat. 1186; renumbered § 542 and amended Pub. L. 101–629, § 19(a)(1)(B), (2)(H), (3), (4), Nov. 28, 1990, 104 Stat. 4529, 4530; Pub. L. 103–80, § 4(a)(2), Aug. 13, 1993, 107 Stat. 779.)
heading: Editorial Notes
heading: Codification
text: Section was classified to section 263n of Title 42, The Public Health and Welfare, prior to renumbering by Pub. L. 101–629.
heading: Amendments
text: 1993—Pub. L. 103–80 amended directory language of Pub. L. 101–629, § 19(a)(4), which renumbered section 263n of Title 42, The Public Health and Welfare, as this section.
1990—Pub. L. 101–629, § 19(a)(1)(B), (2)(H), substituted “section 360kk” for “section 263f” and “this part” for “this subpart”.
heading: Statutory Notes and Related Subsidiaries
heading: Noninterference With Other Federal Agencies
text: Enactment of this section not to be construed to supersede or limit the functions under any other provision of law of any officer or agency of the United States, see section 4 of Pub. L. 90–602, set out as a note under section 360hh of this title.
21 U.S.C. § 360aaa...360aaa–6 (FOOD AND DRUGS)
§§ 360aaa to 360aaa–6. Omitted
heading: Editorial Notes
heading: Codification
text: Sections 360aaa to 360aaa–6 ceased to be effective pursuant to section 401(e) of Pub. L. 105–115, set out as an Effective and Termination Dates note below.
Section 360aaa, act June 25, 1938, ch. 675, § 551, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2356, related to requirements for dissemination of treatment information on drugs or devices.
Section 360aaa–1, act June 25, 1938, ch. 675, § 552, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2358, related to information authorized to be disseminated under section 360aaa.
Section 360aaa–2, act June 25, 1938, ch. 675, § 553, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2359, related to establishment of list of articles and publications disseminated and list of providers that received articles and reference publications.
Section 360aaa–3, act June 25, 1938, ch. 675, § 554, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2359, related to requirement regarding submission of supplemental application for new use and an exemption from that requirement.
Section 360aaa–4, act June 25, 1938, ch. 675, § 555, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2361, related to corrective actions and cessation of dissemination.
Section 360aaa–5, act June 25, 1938, ch. 675, § 556, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2362, related to definitions.
Section 360aaa–6, act June 25, 1938, ch. 675, § 557, as added Pub. L. 105–115, title IV, § 401(a), Nov. 21, 1997, 111 Stat. 2363, related to rules of construction.
heading: Statutory Notes and Related Subsidiaries
heading: Effective and Termination Dates
text: Pub. L. 105–115, title IV, § 401(d), Nov. 21, 1997, 111 Stat. 2364, provided that: “The amendments made by this section [enacting this part and amending section 331 of this title] shall take effect 1 year after the date of enactment of this Act [Nov. 21, 1997], or upon the Secretary’s issuance of final regulations pursuant to subsection (c) [section 401(c) of Pub. L. 105–115 set out below] [Such regulations were issued effective Nov. 20, 1998. See 63 F.R. 64556.], whichever is sooner.”
Pub. L. 105–115, title IV, § 401(e), Nov. 21, 1997, 111 Stat. 2364, provided that: “The amendments made by this section [enacting this part and amending section 331 of this title] cease to be effective September 30, 2006, or 7 years after the date on which the Secretary promulgates the regulations described in subsection (c) [section 401(c) of Pub. L. 105–115 set out below] [Such regulations were issued effective Nov. 20, 1998. See 63 F.R. 64556.], whichever is later.”
heading: Regulations
text: Pub. L. 105–115, title IV, § 401(c), Nov. 21, 1997, 111 Stat. 2364, provided that: “Not later than 1 year after the date of enactment of this Act [Nov. 21, 1997], the Secretary of Health and Human Services shall promulgate regulations to implement the amendments made by this section [enacting this part and amending section 331 of this title].”
21 U.S.C. § 360bbb–0 (FOOD AND DRUGS)
§ 360bbb–0. Expanded access policy required for investigational drugs
(a) In general
The manufacturer or distributor of one or more investigational drugs for the diagnosis, monitoring, or treatment of one or more serious diseases or conditions shall make available the policy of the manufacturer or distributor on evaluating and responding to requests submitted under section 360bbb(b) of this title for provision of such a drug.
(b) Public availability of expanded access policy
The policies under subsection (a) shall be made public and readily available, such as by posting such policies on a publicly available Internet website. Such policies may be generally applicable to all investigational drugs of such manufacturer or distributor.
(c) Content of policy
A policy described in subsection (a) shall include—
(1) contact information for the manufacturer or distributor to facilitate communication about requests described in subsection (a);
(2) procedures for making such requests;
(3) the general criteria the manufacturer or distributor will use to evaluate such requests for individual patients, and for responses to such requests;
(4) the length of time the manufacturer or distributor anticipates will be necessary to acknowledge receipt of such requests; and
(5) a hyperlink or other reference to the clinical trial record containing information about the expanded access for such drug that is required under section 282(j)(2)(A)(ii)(II)(gg) of title 42.
(d) No guarantee of access
The posting of policies by manufacturers and distributors under subsection (a) shall not serve as a guarantee of access to any specific investigational drug by any individual patient.
(e) Revised policy
Nothing in this section shall prevent a manufacturer or distributor from revising a policy required under this section at any time.
(f) Application
This section shall apply to a manufacturer or distributor with respect to an investigational drug beginning on the earlier of—
(1) the first initiation of a phase 2 or phase 3 study (as such terms are defined in section 312.21(b) and (c) of title 21, Code of Federal Regulations (or any successor regulations)) with respect to such investigational drug; or
(2) as applicable, 15 days after the drug receives a designation as a breakthrough therapy, fast track product, or regenerative advanced therapy under subsection (a), (b), or (g), respectively, of section 356 of this title.
(June 25, 1938, ch. 675, § 561A, as added Pub. L. 114–255, div. A, title III, § 3032, Dec. 13, 2016, 130 Stat. 1100; amended Pub. L. 115–52, title VI, § 610(c), Aug. 18, 2017, 131 Stat. 1053.)
heading: Editorial Notes
heading: Amendments
text: 2017—Subsec. (f). Pub. L. 115–52 substituted “earlier” for “later” in introductory provisions, added par. (2), redesignated former par. (2) as (1), and struck out former par. (1) which read as follows: “the date that is 60 calendar days after December 13, 2016; or”.
21 U.S.C. § 360bbb–1 (FOOD AND DRUGS)
§ 360bbb–1. Dispute resolution
If, regarding an obligation concerning drugs or devices under this Act or section 351 of the Public Health Service Act [42 U.S.C. 262], there is a scientific controversy between the Secretary and a person who is a sponsor, applicant, or manufacturer and no specific provision of the Act involved, including a regulation promulgated under such Act, provides a right of review of the matter in controversy, the Secretary shall, by regulation, establish a procedure under which such sponsor, applicant, or manufacturer may request a review of such controversy, including a review by an appropriate scientific advisory panel described in section 355(n) of this title or an advisory committee described in section 360e(g)(2)(B) of this title. Any such review shall take place in a timely manner. The Secretary shall promulgate such regulations within 1 year after November 21, 1997.
(June 25, 1938, ch. 675, § 562, as added Pub. L. 105–115, title IV, § 404, Nov. 21, 1997, 111 Stat. 2368.)
heading: Editorial Notes
heading: References in Text
text: This Act, referred to in text, is the Federal Food, Drug, and Cosmetic Act, act June 25, 1938, ch. 675, 52 Stat. 1040, as amended, which is classified generally to this chapter. For complete classification of this Act to the Code, see section 301 of this title and Tables.
heading: Statutory Notes and Related Subsidiaries
heading: Effective Date
text: Section effective 90 days after Nov. 21, 1997, except as otherwise provided, see section 501 of Pub. L. 105–115, set out as an Effective Date of 1997 Amendment note under section 321 of this title.