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21 U.S.C. § 360d — Performance standards

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21 U.S.C. § 360d — Performance standards

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Source location: Title 21, Chapter 9, § 360d; chapter-009-federal-food-drug-and-cosmetic-act.md

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**(a) Reasonable assurance of safe and effective performance; periodic evaluation** (1) The special controls required by [section 360c(a)(1)(B) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/a/1/B&num=0&edition=prelim) shall include performance standards for a class II device if the Secretary determines that a performance standard is necessary to provide reasonable assurance of the safety and effectiveness of the device. A class III device may also be considered a class II device for purposes of establishing a standard for the device under subsection (b) if the device has been reclassified as a class II device under an administrative order under [section 360c(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/e&num=0&edition=prelim) (or a regulation promulgated under such section prior to July 9, 2012) but such order (or regulation) provides that the reclassification is not to take effect until the effective date of such a standard for the device. (2) A performance standard established under subsection (b) for a device— (A) shall include provisions to provide reasonable assurance of its safe and effective performance; (B) shall, where necessary to provide reasonable assurance of its safe and effective performance, include— (i) provisions respecting the construction, components, ingredients, and properties of the device and its compatibility with power systems and connections to such systems, (ii) provisions for the testing (on a sample basis or, if necessary, on an individual basis) of the device or, if it is determined that no other more practicable means are available to the Secretary to assure the conformity of the device to the standard, provisions for the testing (on a sample basis or, if necessary, on an individual basis) by the Secretary or by another person at the direction of the Secretary, (iii) provisions for the measurement of the performance characteristics of the device, (iv) provisions requiring that the results of each or of certain of the tests of the device required to be made under clause (ii) show that the device is in conformity with the portions of the standard for which the test or tests were required, and (v) a provision requiring that the sale and distribution of the device be restricted but only to the extent that the sale and distribution of a device may be restricted under a regulation under [section 360j(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/e&num=0&edition=prelim); and (C) shall, where appropriate, require the use and prescribe the form and content of labeling for the proper installation, maintenance, operation, and use of the device. (3) The Secretary shall provide for periodic evaluation of performance standards established under subsection (b) to determine if such standards should be changed to reflect new medical, scientific, or other technological data. (4) In carrying out his duties under this subsection and subsection (b), the Secretary shall, to the maximum extent practicable— (A) use personnel, facilities, and other technical support available in other Federal agencies, (B) consult with other Federal agencies concerned with standard-setting and other nationally or internationally recognized standard-setting entities, and (C) invite appropriate participation, through joint or other conferences, workshops, or other means, by informed persons representative of scientific, professional, industry, or consumer organizations who in his judgment can make a significant contribution. **(b) Establishment of a standard** (1) (A) The Secretary shall publish in the Federal Register a notice of proposed rulemaking for the establishment, amendment, or revocation of any performance standard for a device. (B) A notice of proposed rulemaking for the establishment or amendment of a performance standard for a device shall— (i) set forth a finding with supporting justification that the performance standard is appropriate and necessary to provide reasonable assurance of the safety and effectiveness of the device, (ii) set forth proposed findings with respect to the risk of illness or injury that the performance standard is intended to reduce or eliminate, (iii) invite interested persons to submit to the Secretary, within 30 days of the publication of the notice, requests for changes in the classification of the device pursuant to [section 360c(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/e&num=0&edition=prelim) based on new information relevant to the classification, and (iv) invite interested persons to submit an existing performance standard for the device, including a draft or proposed performance standard, for consideration by the Secretary. (C) A notice of proposed rulemaking for the revocation of a performance standard shall set forth a finding with supporting justification that the performance standard is no longer necessary to provide reasonable assurance of the safety and effectiveness of a device. (D) The Secretary shall provide for a comment period of not less than 60 days. (2) If, after publication of a notice in accordance with paragraph (1), the Secretary receives a request for a change in the classification of the device, the Secretary shall, within 60 days of the publication of the notice, after consultation with the appropriate panel under [section 360c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c&num=0&edition=prelim), either deny the request or give notice of an intent to initiate such change under [section 360c(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/e&num=0&edition=prelim). (3) (A) After the expiration of the period for comment on a notice of proposed rulemaking published under paragraph (1) respecting a performance standard and after consideration of such comments and any report from an advisory committee under paragraph (5), the Secretary shall (i) promulgate a regulation establishing a performance standard and publish in the Federal Register findings on the matters referred to in paragraph (1), or (ii) publish a notice terminating the proceeding for the development of the standard together with the reasons for such termination. If a notice of termination is published, the Secretary shall (unless such notice is issued because the device is a banned device under [section 360f of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360f&num=0&edition=prelim)) initiate a proceeding under [section 360c(e) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/e&num=0&edition=prelim) to reclassify the device subject to the proceeding terminated by such notice. (B) A regulation establishing a performance standard shall set forth the date or dates upon which the standard shall take effect, but no such regulation may take effect before one year after the date of its publication unless (i) the Secretary determines that an earlier effective date is necessary for the protection of the public health and safety, or (ii) such standard has been established for a device which, effective upon the effective date of the standard, has been reclassified from class III to class II. Such date or dates shall be established so as to minimize, consistent with the public health and safety, economic loss to, and disruption or dislocation of, domestic and international trade. (4) (A) The Secretary, upon his own initiative or upon petition of an interested person may by regulation, promulgated in accordance with the requirements of paragraphs (1), (2), and (3)(B) of this subsection, amend or revoke a performance standard. (B) The Secretary may declare a proposed amendment of a performance standard to be effective on and after its publication in the Federal Register and until the effective date of any final action taken on such amendment if he determines that making it so effective is in the public interest. A proposed amendment of a performance standard made so effective under the preceding sentence may not prohibit, during the period in which it is so effective, the introduction or delivery for introduction into interstate commerce of a device which conforms to such standard without the change or changes provided by such proposed amendment. (5) (A) The Secretary— (i) may on his own initiative refer a proposed regulation for the establishment, amendment, or revocation of a performance standard, or (ii) shall, upon the request of an interested person which demonstrates good cause for referral and which is made before the expiration of the period for submission of comments on such proposed regulation refer such proposed regulation, to an advisory committee of experts, established pursuant to subparagraph (B), for a report and recommendation with respect to any matter involved in the proposed regulation which requires the exercise of scientific judgment. If a proposed regulation is referred under this subparagraph to an advisory committee, the Secretary shall provide the advisory committee with the data and information on which such proposed regulation is based. The advisory committee shall, within sixty days of the referral of a proposed regulation and after independent study of the data and information furnished to it by the Secretary and other data and information before it, submit to the Secretary a report and recommendation respecting such regulation, together with all underlying data and information and a statement of the reason or basis for the recommendation. A copy of such report and recommendation shall be made public by the Secretary. (B) The Secretary shall establish advisory committees (which may not be panels under [section 360c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c&num=0&edition=prelim)) to receive referrals under subparagraph (A). The Secretary shall appoint as members of any such advisory committee persons qualified in the subject matter to be referred to the committee and of appropriately diversified professional background, except that the Secretary may not appoint to such a committee any individual who is in the regular full-time employ of the United States and engaged in the administration of this chapter. Each such committee shall include as nonvoting members a representative of consumer interests and a representative of interests of the device manufacturing industry. Members of an advisory committee who are not officers or employees of the United States, while attending conferences or meetings of their committee or otherwise serving at the request of the Secretary, shall be entitled to receive compensation at rates to be fixed by the Secretary, which rates may not exceed the daily equivalent of the rate in effect for grade GS–18 of the General Schedule, for each day (including traveltime) they are so engaged; and while so serving away from their homes or regular places of business each member may be allowed travel expenses, including per diem in lieu of subsistence, as authorized by [section 5703 of title 5](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section5703&num=0&edition=prelim) for persons in the Government service employed intermittently. The Secretary shall designate one of the members of each advisory committee to serve as chairman thereof. The Secretary shall furnish each advisory committee with clerical and other assistance, and shall by regulation prescribe the procedures to be followed by each such committee in acting on referrals made under subparagraph (A). **(c) Recognition of standard** (1) (A) In addition to establishing a performance standard under this section, the Secretary shall, by publication in the Federal Register (or, with respect to a susceptibility test interpretive criteria standard under [section 360a–2 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360a-2&num=0&edition=prelim), by posting on the Interpretive Criteria Website in accordance with such section), recognize all or part of an appropriate standard established by a nationally or internationally recognized standard development organization for which a person may submit a declaration of conformity in order to meet a premarket submission requirement or other requirement under this chapter to which such standard is applicable. (B) If a person elects to use a standard recognized by the Secretary under subparagraph (A) to meet the requirements described in such subparagraph, the person shall provide a declaration of conformity to the Secretary that certifies that the device is in conformity with such standard. A person may elect to use data, or information, other than data required by a standard recognized under subparagraph (A) to meet any requirement regarding devices under this chapter. (C) (i) Any person may submit a request for recognition under subparagraph (A) of all or part of an appropriate standard established by a nationally or internationally recognized standard organization.11 So in original. Probably should be “standard development organization.” (ii) Not later than 60 calendar days after the Secretary receives such a request, the Secretary shall— (I) make a determination to recognize all, part, or none of the standard that is the subject of the request; and (II) issue to the person who submitted such request a response in writing that states the Secretary’s rationale for that determination, including the scientific, technical, regulatory, or other basis for such determination. (iii) The Secretary shall make a response issued under clause (ii)(II) publicly available, in such a manner as the Secretary determines appropriate. (iv) The Secretary shall take such actions as may be necessary to implement all or part of a standard recognized under clause (ii)(I), in accordance with subparagraph (A). (D) The Secretary shall make publicly available, in such manner as the Secretary determines appropriate, the rationale for recognition under subparagraph (A) of all, part, or none of a standard, including the scientific, technical, regulatory, or other basis for the decision regarding such recognition. (2) The Secretary may withdraw such recognition of a standard through publication of a notice in the Federal Register if the Secretary determines that the standard is no longer appropriate for meeting a requirement regarding devices under this chapter. (3) (A) Subject to subparagraph (B), the Secretary shall accept a declaration of conformity that a device is in conformity with a standard recognized under paragraph (1) unless the Secretary finds— (i) that the data or information submitted to support such declaration does not demonstrate that the device is in conformity with the standard identified in the declaration of conformity; or (ii) that the standard identified in the declaration of conformity is not applicable to the particular device under review. (B) The Secretary may request, at any time, the data or information relied on by the person to make a declaration of conformity with respect to a standard recognized under paragraph (1). (C) A person making a declaration of conformity with respect to a standard recognized under paragraph (1) shall maintain the data and information demonstrating conformity of the device to the standard for a period of two years after the date of the classification or approval of the device by the Secretary or a period equal to the expected design life of the device, whichever is longer. (4) The Secretary shall provide to all employees of the Food and Drug Administration who review premarket submissions for devices periodic training on the concept and use of recognized standards for purposes of meeting a premarket submission requirement or other applicable requirement under this chapter, including standards relevant to an employee’s area of device review. **(d) Accreditation scheme for conformity assessment** (1) **In general** — The Secretary shall establish a program under which— (A) testing laboratories meeting criteria specified in guidance by the Secretary may be accredited, by accreditation bodies meeting criteria specified in guidance by the Secretary, to conduct testing to support the assessment of the conformity of a device to certain standards recognized under this section; and (B) subject to paragraph (2), results from tests conducted to support the assessment of conformity of devices as described in subparagraph (A) conducted by testing laboratories accredited pursuant to this subsection shall be accepted by the Secretary for purposes of demonstrating such conformity unless the Secretary finds that certain results of such tests should not be so accepted. (2) **Secretarial review of accredited laboratory results** — The Secretary may— (A) review the results of tests conducted by testing laboratories accredited pursuant to this subsection, including by conducting periodic audits of such results or of the processes of accredited bodies or testing laboratories; (B) following such review, take additional measures under this chapter, as the Secretary determines appropriate, such as— (i) suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under paragraph (1)(A); or (ii) requesting additional information with respect to a device; and (C) if the Secretary becomes aware of information materially bearing on the safety or effectiveness of a device for which an assessment of conformity was supported by testing conducted by a testing laboratory accredited under this subsection, take such additional measures under this chapter, as the Secretary determines appropriate, such as— (i) suspension or withdrawal of accreditation of a testing laboratory or recognition of an accreditation body under paragraph (1)(A); or (ii) requesting additional information with regard to such device. (3) **Report** — The Secretary shall make available on the internet website of the Food and Drug Administration an annual report on the progress of the program under this subsection.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 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 for one or more intended uses; 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 or to make such intended use or uses a banned intended use or uses. A device that is banned for one or more intended uses is not a legally marketed device under [section 396 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section396&num=0&edition=prelim) when intended for such use or uses. **(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,

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Federal law — U.S. Code and appendices · legal_authorities

5 U.S.C. § 1013 — Termination of advisory committees

**(a) In General.—** (1) **Advisory committees in existence on january 5, 1973.—** — Each advisory committee that is in existence on January 5, 1973, shall terminate not later than the expiration of the 2-year period following that date unless— (A) in the case of an advisory committee established by the President or an officer of the Federal Government, such advisory committee is renewed by the President or that officer by appropriate action prior to the expiration of such 2-year period; or (B) in the case of an advisory committee established by an Act of Congress, its duration is otherwise provided for by law. (2) **Advisory committees established after january 5, 1973.—** — Each advisory committee established after January 5, 1973, shall terminate not later than the expiration of the 2-year period beginning on the date of its establishment unless— (A) in the case of an advisory committee established by the President or an officer of the Federal Government 11 So in original. Probably should be followed by a comma. such advisory committee is renewed by the President or such officer by appropriate action prior to the end of such period; or (B) in the case of an advisory committee established by an Act of Congress, its duration is otherwise provided for by law. **(b) Charters.—** (1) **Upon renewal.—** — Upon the renewal of an advisory committee, the advisory committee shall file a charter in accordance with [section 1008(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title5-section1008/c&num=0&edition=prelim). (2) **Upon expiration of successive 2-year periods.—** — An advisory committee established by an Act of Congress shall file a charter in accordance with [section 1008(c) of this title](https://uscode.house.gov/view.x

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Federal law — U.S. Code and appendices · legal_authorities

5 U.S.C. § 5376 — Pay for certain senior-level positions

**(a)** This section applies to— (1) positions that are classified above GS–15 pursuant to section 5108; and (2) scientific or professional positions established under section 3104; but does not apply to— (A) any Senior Executive Service position under section 3132; or (B) any position in the Federal Bureau of Investigation and Drug Enforcement Administration Senior Executive Service under section 3151. **(b)** (1) Subject to such regulations as the Office of Personnel Management prescribes, the head of the agency concerned shall fix the rate of basic pay for any position within such agency to which this section applies. A rate fixed under this section shall be— (A) not less than 120 percent of the minimum rate of basic pay payable for GS–15 of the General Schedule; and (B) subject to paragraph (3), not greater than the rate of basic pay payable for level III of the Executive Schedule. The payment of a rate of basic pay under this section shall not be subject to the pay limitation of section 5306(e) or 5373. (2) Subject to paragraph (1), effective at the beginning of the first applicable pay period commencing on or after the first day of the month in which an adjustment takes effect under section 5303 in the rates of pay under the General Schedule, each rate of pay established under this section for positions within an agency shall be adjusted by such amount as the head of such agency considers appropriate. (3) In the case of an agency which has a performance appraisal system which, as designed and applied, is certified under section 5307(d) as making meaningful distinctions based on relative performance, paragraph (1)(B) shall apply as if the reference to “level III” were a reference to “level II”. (4) No employee may suffer a reduction in pay by reaso

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 356 — Expedited approval of drugs for serious or life-threatening diseases or conditions

**(a) Designation of a drug as a breakthrough therapy** (1) **In general** — The Secretary shall, at the request of the sponsor of a drug, expedite the development and review of such drug if the drug is intended, alone or in combination with 1 or more other drugs, to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on 1 or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. (In this section, such a drug is referred to as a “breakthrough therapy”.) (2) **Request for designation** — The sponsor of a drug may request the Secretary to designate the drug as a breakthrough therapy. A request for the designation may be made concurrently with, or at any time after, the submission of an application for the investigation of the drug under [section 355(i) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355/i&num=0&edition=prelim) or section 351(a)(3) of the Public Health Service Act [[42 U.S.C. 262(a)(3)](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262/a/3&num=0&edition=prelim)]. (3) **Designation** (A) *In general* — Not later than 60 calendar days after the receipt of a request under paragraph (2), the Secretary shall determine whether the drug that is the subject of the request meets the criteria described in paragraph (1). If the Secretary finds that the drug meets the criteria, the Secretary shall designate the drug as a breakthrough therapy and shall take such actions as are appropriate to expedite the development and review of the application for approval of such drug. (B) *Actions* — The actions to

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21 U.S.C. § 321 — Definitions; generally

For the purposes of this chapter— **(a)** (1) The term “State”, except as used in the last sentence of [section 372(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section372/a&num=0&edition=prelim), means any State or Territory of the United States, the District of Columbia, and the Commonwealth of Puerto Rico. (2) The term “Territory” means any Territory or possession of the United States, including the District of Columbia, and excluding the Commonwealth of Puerto Rico and the Canal Zone. **(b)** The term “interstate commerce” means (1) commerce between any State or Territory and any place outside thereof, and (2) commerce within the District of Columbia or within any other Territory not organized with a legislative body. **(c)** The term “Department” means Department of Health and Human Services. **(d)** The term “Secretary” means the Secretary of Health and Human Services. **(e)** The term “person” includes individual, partnership, corporation, and association. **(f)** The term “food” means (1) articles used for food or drink for man or other animals, (2) chewing gum, and (3) articles used for components of any such article. **(g)** (1) The term “drug” means (A) articles recognized in the official United States Pharmacopoeia,11 So in original. Probably should be “Pharmacopeia,”. official Homoeopathic Pharmacopoeia of the United States, or official National Formulary, or any supplement to any of them; and (B) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals; and (D) articles intended for use as a component of any article specif

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Federal law — U.S. Code and appendices · legal_authorities

5 U.S.C. § 5703 — Per diem, travel, and transportation expenses; experts and consultants; individuals serving without pay

An employee serving intermittently in the Government service as an expert or consultant and paid on a daily when-actually-employed basis, or serving without pay or at $1 a year, may be allowed travel or transportation expenses, under this subchapter, while away from his home or regular place of business and at the place of employment or service.

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 379i — Definitions

For purposes of this subpart: (1) The term “premarket application” means— (A) an application for approval of a device submitted under [section 360e(c) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/c&num=0&edition=prelim) or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim); or (B) a product development protocol described in [section 360e(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/f&num=0&edition=prelim). Such term does not include a supplement, a premarket report, or a premarket notification submission. (2) The term “premarket report” means a report submitted under [section 360e(c)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/c/2&num=0&edition=prelim). (3) The term “premarket notification submission” means a report submitted under [section 360(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360/k&num=0&edition=prelim). (4) (A) The term “supplement”, with respect to a panel-track supplement, a 180-day supplement, a real-time supplement, or an efficacy supplement, means a request to the Secretary to approve a change in a device for which— (i) an application or report has been approved under [section 360e(d) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/d&num=0&edition=prelim), or an application has been approved under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim); or (ii) a notice of completion has become effective under [section 360e(f) o

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 360c — Classification of devices intended for human use

**(a) Classes of devices** (1) There are established the following classes of devices intended for human use: (A) *Class I, General Controls.—* (i) A device for which the controls authorized by or under section 351, 352, 360, 360f, 360h, 360i, or 360j of this title or any combination of such sections are sufficient to provide reasonable assurance of the safety and effectiveness of the device. (ii) A device for which insufficient information exists to determine that the controls referred to in clause (i) are sufficient to provide reasonable assurance of the safety and effectiveness of the device or to establish special controls to provide such assurance, but because it— (I) is not purported or represented to be for a use in supporting or sustaining human life or for a use which is of substantial importance in preventing impairment of human health, and (II) does not present a potential unreasonable risk of illness or injury, is to be regulated by the controls referred to in clause (i). (B) *Class II, Special Controls.—* — A device which cannot be classified as a class I device because the general controls by themselves are insufficient to provide reasonable assurance of the safety and effectiveness of the device, and for which there is sufficient information to establish special controls to provide such assurance, including the promulgation of performance standards, postmarket surveillance, patient registries, development and dissemination of guidelines (including guidelines for the submission of clinical data in premarket notification submissions in accordance with [section 360(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360/k&num=0&edition=prelim)), recommendations, and other appropri

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Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 351 — Adulterated drugs and devices

A drug or device shall be deemed to be adulterated— **(a) Poisonous, insanitary, etc., ingredients; adequate controls in manufacture** (1) If it consists in whole or in part of any filthy, putrid, or decomposed substance; or (2)(A) if it has been prepared, packed, or held under insanitary conditions whereby it may have been contaminated with filth, or whereby it may have been rendered injurious to health; or (B) if it is a drug and the methods used in, or the facilities or controls used for, its manufacture, processing, packing, or holding do not conform to or are not operated or administered in conformity with current good manufacturing practice to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, which it purports or is represented to possess; or (C) if it is a compounded positron emission tomography drug and the methods used in, or the facilities and controls used for, its compounding, processing, packing, or holding do not conform to or are not operated or administered in conformity with the positron emission tomography compounding standards and the official monographs of the United States Pharmacopoeia to assure that such drug meets the requirements of this chapter as to safety and has the identity and strength, and meets the quality and purity characteristics, that it purports or is represented to possess; or (3) if its container is composed, in whole or in part, of any poisonous or deleterious substance which may render the contents injurious to health; or (4) if (A) it bears or contains, for purposes of coloring only, a color additive which is unsafe within the meaning of [section 379e(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 351

Stored review status: release_metadata_unconfirmed. Incoming connection: Explicit cross-reference supplied in source Markdown; currentness and applicability require review.

Federal law — U.S. Code and appendices · legal_authorities

21 U.S.C. § 352 — Misbranded drugs and devices

A drug or device shall be deemed to be misbranded— **(a) False or misleading label** (1) If its labeling is false or misleading in any particular. Health care economic information provided to a payor, formulary committee, or other similar entity with knowledge and expertise in the area of health care economic analysis, carrying out its responsibilities for the selection of drugs or devices for coverage or reimbursement, shall not be considered to be false or misleading under this paragraph if the health care economic information relates to an indication approved under section 355, 360(k), 360c(f)(2), or 360e of this title or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for such drug or device, is based on competent and reliable scientific evidence, and includes, where applicable, a conspicuous and prominent statement describing any material differences between the health care economic information and the labeling approved for the drug or device under section 355, 360(k), 360c(f)(2), or 360e of this title or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). The requirements set forth in section 355, 360(k), 360c(f)(2), or 360e of this title or [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) shall not apply to health care economic information provided to such a payor, committee, or entity in accordance with this paragraph. Information that is relevant to the substantiation of the health care economic information presented pursuant to this paragraph shall be made available to the Secretary upon request. (2) (A) For purposes of th

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 352

Stored review status: release_metadata_unconfirmed. Incoming connection: Explicit cross-reference supplied in source Markdown; currentness and applicability require review.