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21 U.S.C. § 360f — Banned devices
Federal law — U.S. Code and appendices · legal_authorities
**(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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Stable record: federal_law:legal_authorities:record_usc_1d64ef142b20c60c58689170
Source file: Laws/federal/codes/united-states-code/title-21/section-360f-banned-devices--67d61982b4.md
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Source location: Title 21, Chapter 9, § 360f; chapter-009-federal-food-drug-and-cosmetic-act.md
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**(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, 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.
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Federal law — U.S. Code and appendices · legal_authorities
Nothing in this chapter shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not change any existing prohibition on the promotion of unapproved uses of legally marketed devices.
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 396
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Federal law — U.S. Code and appendices · legal_authorities
**(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360c
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Federal law — U.S. Code and appendices · legal_authorities
**(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
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360d
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Federal law — U.S. Code and appendices · legal_authorities
**(a) General requirement** A class III device—
(1) which is subject to an order issued under subsection (b) (or a regulation promulgated under such subsection prior to July 9, 2012); or
(2) which is a class III device because of [section 360c(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/f&num=0&edition=prelim),
is required to have, unless exempt under [section 360j(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/g&num=0&edition=prelim), an approval under this section of an application for premarket approval or, as applicable, an approval under subsection (c)(2) of a report seeking premarket approval.
**(b) Order to require premarket approval**
(1) In the case of a class III device which—
(A) was introduced or delivered for introduction into interstate commerce for commercial distribution before May 28, 1976; or
(B) is (i) of a type so introduced or delivered, and (ii) is substantially equivalent to another device within that type,
the Secretary shall by administrative order following publication of a proposed order in the Federal Register, a meeting of a device classification panel described in [section 360c(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/b&num=0&edition=prelim), and consideration of comments from all affected stakeholders, including patients, payors, and providers, notwithstanding subchapter II of chapter 5 of title 5, require that such device have an approval under this section of an application for premarket approval. Authority to issue such administrative order shall not be delegated below the Director of the Center for Devices and Radiological Health, acting in consultation with the
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360e
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Petition; record** Not later than thirty days after—
(1) the promulgation of a regulation under [section 360c of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c&num=0&edition=prelim) classifying a device in class I, an administrative order changing the classification of a device to class I, or an order under subsection (f)(2) of such section reclassifying a device or denying a petition for reclassification of a device,
(2) the promulgation of a regulation under [section 360d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360d&num=0&edition=prelim) establishing, amending, or revoking a performance standard for a device,
(3) the issuance of an order under section 360d(b)(2) or 360e(b)(2)(B) of this title denying a request for reclassification of a device,
(4) the promulgation of a regulation under paragraph (3) of [section 360e(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/b&num=0&edition=prelim) requiring a device to have an approval of a premarket application, a regulation under paragraph (4) of that section amending or revoking a regulation under paragraph (3), or an order pursuant to section 360e(g)(1) or 360e(g)(2)(C) of this title,
(5) the promulgation of a regulation under [section 360f of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360f&num=0&edition=prelim) (other than a proposed regulation made effective under subsection (b) of such section upon the regulation’s publication) making a device a banned device,
(6) the issuance of an order under [section 360j(f)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/f/2&num=0&ed
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360g
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Federal law — U.S. Code and appendices · legal_authorities
**(a) General rule** Any requirement authorized by or under section 351, 352, 360, or 360i of this title applicable to a device intended for human use shall apply to such device until the applicability of the requirement to the device has been changed by action taken under section 360c, 360d, or 360e of this title or under subsection (g) of this section, and any requirement established by or under section 351, 352, 360, or 360i of this title which is inconsistent with a requirement imposed on such device under section 360d or 360e of this title or under subsection (g) of this section shall not apply to such device.
**(b) Custom devices**
(1) **In general** — The requirements of sections 360d and 360e of this title shall not apply to a device that—
(A) is created or modified in order to comply with the order of an individual physician or dentist (or any other specially qualified person designated under regulations promulgated by the Secretary after an opportunity for an oral hearing);
(B) in order to comply with an order described in subparagraph (A), necessarily deviates from an otherwise applicable performance standard under [section 360d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360d&num=0&edition=prelim) or requirement under [section 360e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e&num=0&edition=prelim);
(C) is not generally available in the United States in finished form through labeling or advertising by the manufacturer, importer, or distributor for commercial distribution;
(D) is designed to treat a unique pathology or physiological condition that no other device is domestically available to treat;
(E)
(i) is intended to meet the special need
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 360j
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Imports; list of registered foreign establishments; samples from unregistered foreign establishments; examination and refusal of admission** The Secretary of the Treasury shall deliver to the Secretary of Health and Human Services, upon his request, samples of food, drugs, devices, tobacco products, and cosmetics which are being imported or offered for import into the United States, giving notice thereof to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. The Secretary of Health and Human Services shall furnish to the Secretary of the Treasury a list of establishments registered pursuant to subsection (i) of section 360 or [section 387e(h) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section387e/h&num=0&edition=prelim) and shall request that if any drugs, devices, or tobacco products manufactured, prepared, propagated, compounded, or processed in an establishment not so registered are imported or offered for import into the United States, samples of such drugs, devices, or tobacco products be delivered to the Secretary of Health and Human Services, with notice of such delivery to the owner or consignee, who may appear before the Secretary of Health and Human Services and have the right to introduce testimony. If it appears from the examination of such samples or otherwise that (1) such article has been manufactured, processed, or packed under insanitary conditions or, in the case of a device, the methods used in, or the facilities or controls used for, the manufacture, packing, storage, or installation of the device do not conform to the requirements of [section 360j(f) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 381
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Federal law — U.S. Code and appendices · legal_authorities
**(a) Drugs or devices intended for human or animal use which require approval or licensing** A drug or device—
(1) which, in the case of a drug—
(A)
(i) requires approval by the Secretary under [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) before such drug may be introduced or delivered for introduction into interstate commerce; or
(ii) requires licensing by the Secretary under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) or by the Secretary of Agriculture under the Act of March 4, 1913 [[21 U.S.C. 151](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section151&num=0&edition=prelim) et seq.] (known as the Virus-Serum Toxin Act) before it may be introduced or delivered for introduction into interstate commerce;
(B) does not have such approval or license; and
(C) is not exempt from such sections or Act; and
(2) which, in the case of a device—
(A) does not comply with an applicable requirement under section 360d or 360e of this title;
(B) under [section 360j(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/g&num=0&edition=prelim) is exempt from either such section; or
(C) 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), is adulterated, misbranded, and in violation of such sections or Act unless the export of the drug or device is, except as provided in subsection (f), authorized under subsection (b), (c), (d), or (e) or [section 381(e)(2) of this title](https://uscode.house.gov/view.xhtml?req=granuleid
Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 382
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Federal law — U.S. Code and appendices · legal_authorities
Page 359
TITLE 21—FOOD AND DRUGS
§ 360f
and effective use of the device as such device
changes pursuant to such plan, notification re-
quirements if the device does not function as
intended pursuant to such plan, and perform-
ance requirements for changes made under the
plan.
(b) Cleared devices
(1) In general
Notwithstanding section 360(k) of this title,
a premarket notification shall not be required
for a change to a device cleared under section
360(k) of this title, if such change is consistent
with an established predetermined change con-
trol plan granted pursuant to paragraph (2).
(2) Predetermined change control plan
The Secretary may clear a predetermined
change control plan submitted in a notifica-
tion submitted under section 360(k) of this
title that describes planned changes that may
be made to the device (and that would other-
wise require a new notification), if—
(A) the device remains safe and effective
without any such change; and
(B) the device would remain substantially
equivalent to the predicate.
(3) Scope
The Secretary may require that a change
control plan include labeling required for safe
and effective use of the device as such device
changes pursuant to such plan, notification re-
quirements if the device does not function as
intended pursuant to such plan, and perform-
ance requirements for changes made under the
plan.
(c) Predicate devices
In making a determination of substantial
equivalence pursuant to section 360c(i) of this
title, the Secretary shall not compare a device
to changed versions of a device implemented in
accordance with an established predetermined
change control plan as a predicate device. Only
the version of the device cleared or approved,
prior to changes made under the predetermined
chang
Source: Supplied 2024 U.S. Code historical extraction · 21 U.S.C. § 360f
Stored review status: historical_2024_not_currentness_verified. Same stored citation; legal effect and authority still require review.