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21 U.S.C. § 379i — Definitions

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

21 U.S.C. § 379i — Definitions

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Source location: Title 21, Chapter 9, § 379i; chapter-009-federal-food-drug-and-cosmetic-act.md

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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) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/f&num=0&edition=prelim). (B) The term “panel-track supplement” means a supplement to an approved premarket application or premarket report under [section 360e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e&num=0&edition=prelim) that requests a significant change in design or performance of the device, or a new indication for use of the device, and for which substantial clinical data are necessary to provide a reasonable assurance of safety and effectiveness. (C) The term “180-day supplement” means a supplement to an approved premarket application or premarket report under [section 360e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e&num=0&edition=prelim) that is not a panel-track supplement and requests a significant change in components, materials, design, specification, software, color additives, or labeling. (D) The term “real-time supplement” means a supplement to an approved premarket application or premarket report under [section 360e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e&num=0&edition=prelim) that requests a minor change to the device, such as a minor change to the design of the device, software, sterilization, or labeling, and for which the applicant has requested and the agency has granted a meeting or similar forum to jointly review and determine the status of the supplement. (E) The term “efficacy supplement” means a supplement to an approved premarket application under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) that requires substantive clinical data. (5) The term “30-day notice” means a notice under [section 360e(d)(5) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/d/5&num=0&edition=prelim) that is limited to a request to make modifications to manufacturing procedures or methods of manufacture affecting the safety and effectiveness of the device. (6) The term “request for classification information” means a request made under [section 360c(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/g&num=0&edition=prelim) for information respecting the class in which a device has been classified or the requirements applicable to a device. (7) The term “annual fee”, for periodic reporting concerning a class III device, means the annual fee associated with periodic reports required by a premarket application approval order. (8) The term “de novo classification request” means a request made under [section 360c(f)(2)(A) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/f/2/A&num=0&edition=prelim) with respect to the classification of a device. (9) The term “process for the review of device applications” means the following activities of the Secretary with respect to the review of premarket applications, premarket reports, supplements, premarket notification submissions, and de novo classification requests: (A) The activities necessary for the review of premarket applications, premarket reports, supplements, and premarket notification submissions. (B) The issuance of action letters that allow the marketing of devices or which set forth in detail the specific deficiencies in such applications, reports, supplements, or submissions and, where appropriate, the actions necessary to place them in condition for approval. (C) The inspection of manufacturing establishments and other facilities undertaken as part of the Secretary’s review of pending premarket applications, premarket reports, and supplements. (D) Monitoring of research conducted in connection with the review of such applications, reports, supplements, submissions, and de novo classification requests. (E) Review of device applications subject to [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) for an investigational new drug application 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 for an investigational device exemption under [section 360j(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/g&num=0&edition=prelim) and activities conducted in anticipation of the submission of such applications under section 355(i) or 360j(g) of this title. (F) The development of guidance, policy documents, or regulations to improve the process for the review of premarket applications, premarket reports, supplements, premarket notification submissions, and de novo classification requests. (G) The development of voluntary test methods, consensus standards, or mandatory performance standards under [section 360d of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360d&num=0&edition=prelim) in connection with the review of such applications, reports, supplements, submissions, or requests and related activities. (H) The provision of technical assistance to device manufacturers in connection with the submission of such applications, reports, supplements, submissions, or requests. (I) Any activity undertaken under section 360c or 360e(i) of this title in connection with the initial classification or reclassification of a device or under [section 360e(b) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e/b&num=0&edition=prelim) in connection with any requirement for approval of a device. (J) Evaluation of postmarket studies required as a condition of an approval of a premarket application or premarket report under [section 360e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e&num=0&edition=prelim) or a premarket application under [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim). (K) Compiling, developing, and reviewing information on relevant devices to identify safety and effectiveness issues for devices subject to premarket applications, premarket reports, supplements, premarket notification submissions, or de novo classification requests. (10) The term “costs of resources allocated for the process for the review of device applications” means the expenses in connection with the process for the review of device applications for— (A) officers and employees of the Food and Drug Administration, contractors of the Food and Drug Administration, advisory committees, and costs related to such officers, employees, and committees and to contracts with such contractors; (B) management of information, and the acquisition, maintenance, and repair of computer resources; (C) leasing, maintenance, renovation, and repair of facilities and acquisition, maintenance, and repair of fixtures, furniture, scientific equipment, and other necessary materials and supplies; and (D) collecting fees and accounting for resources allocated for the review of premarket applications, premarket reports, supplements, submissions, and de novo classification requests. (11) The term “adjustment factor” applicable to a fiscal year is the Consumer Price Index for all urban consumers (all items; United States city average) for October of the preceding fiscal year divided by such Index for October 2021. (12) The term “person” includes an affiliate thereof. (13) The term “affiliate” means a business entity that has a relationship with a second business entity (whether domestic or international) if, directly or indirectly— (A) one business entity controls, or has the power to control, the other business entity; or (B) a third party controls, or has power to control, both of the business entities. (14) The term “establishment subject to a registration fee” means an establishment that is registered (or is required to register) with the Secretary under [section 360 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360&num=0&edition=prelim) because such establishment is engaged in the manufacture, preparation, propagation, compounding, or processing of a device.

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

21 U.S.C. § 301 — Short title

This chapter may be cited as the Federal Food, Drug, and Cosmetic Act.

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

21 U.S.C. § 379j — Authority to assess and use device fees

**(a) Types of fees** (1) **In general** — Beginning in fiscal year 2023, the Secretary shall assess and collect fees in accordance with this section. (2) **Premarket application, premarket report, supplement, and submission fee, and annual fee for periodic reporting concerning a class III device** (A) *In general* — Except as provided in subparagraph (B) and subsections (d) and (e), each person who submits any of the following, on or after October 1, 2022, shall be subject to a fee established under subsection (c) for the fiscal year involved in accordance with the following: (i) A premarket application. (ii) For a premarket report, a fee equal to the fee that applies under clause (i). (iii) For a panel track supplement, a fee equal to 80 percent of the fee that applies under clause (i). (iv) For a 180-day supplement, a fee equal to 15 percent of the fee that applies under clause (i). (v) For a real-time supplement, a fee equal to 7 percent of the fee that applies under clause (i). (vi) For a 30-day notice, a fee equal to 1.6 percent of the fee that applies under clause (i). (vii) For an efficacy supplement, a fee equal to the fee that applies under clause (i). (viii) For a premarket notification submission, a fee equal to 4.5 percent of the fee that applies under clause (i). (ix) For a request for classification information, a fee equal to 1.35 percent of the fee that applies under clause (i). (x) For periodic reporting concerning a class III device, an annual fee equal to 3.5 percent of the fee that applies under clause (i). (xi) For a de novo classification request, a fee equal to 30 percent of the fee that applies under clause (i). (B) *Exceptions* (i) *Humanitarian device exemption* — An applicati

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

21 U.S.C. § 360e — Premarket approval

**(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

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

**(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

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42 U.S.C. § 262 — Regulation of biological products

**(a) Biologics license** (1) No person shall introduce or deliver for introduction into interstate commerce any biological product unless— (A) a biologics license under this subsection or subsection (k) is in effect for the biological product; and (B) each package of the biological product is plainly marked with— (i) the proper name of the biological product contained in the package; (ii) the name, address, and applicable license number of the manufacturer of the biological product; and (iii) the expiration date of the biological product. (2) (A) The Secretary shall establish, by regulation, requirements for the approval, suspension, and revocation of biologics licenses. (B) *Pediatric studies.—* — A person that submits an application for a license under this paragraph shall submit to the Secretary as part of the application any assessments required under section 505B of the Federal Food, Drug, and Cosmetic Act [[21 U.S.C. 355c](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355c&num=0&edition=prelim)]. (C) The Secretary shall approve a biologics license application— (i) on the basis of a demonstration that— (I) the biological product that is the subject of the application is safe, pure, and potent; and (II) the facility in which the biological product is manufactured, processed, packed, or held meets standards designed to assure that the biological product continues to be safe, pure, and potent; and (ii) if the applicant (or other appropriate person) consents to the inspection of the facility that is the subject of the application, in accordance with subsection (c). (D) *Postmarket studies and clinical trials; labeling; risk evaluation and mitigation strategy.—* — A person that sub

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21 U.S.C. § 360 — Registration of producers of drugs or devices

**(a) Definitions** As used in this section— (1) the term “manufacture, preparation, propagation, compounding, or processing” shall include repackaging or otherwise changing the container, wrapper, or labeling of any drug package or device package in furtherance of the distribution of the drug or device from the original place of manufacture to the person who makes final delivery or sale to the ultimate consumer or user; and (2) the term “name” shall include in the case of a partnership the name of each partner and, in the case of a corporation, the name of each corporate officer and director, and the State of incorporation. **(b) Annual registration** (1) During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a drug or drugs shall register with the Secretary the name of such person, places of business of such person, all such establishments, the unique facility identifier of each such establishment, and a point of contact e-mail address. (2) During the period beginning on October 1 and ending on December 31 of each year, every person who owns or operates any establishment in any State engaged in the manufacture, preparation, propagation, compounding, or processing of a device or devices shall register with the Secretary his name, places of business, and all such establishments. (3) The Secretary shall specify the unique facility identifier system that shall be used by registrants under paragraph (1). The requirement to include a unique facility identifier in a registration under paragraph (1) shall not apply until the date that the identifier system is specified by the Secretary under the pr

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21 U.S.C. § 360m — Accredited persons

**(a) In general** (1) **Review and classification of devices** — Not later than 1 year after November 21, 1997, the Secretary shall, subject to paragraph (3), accredit persons for the purpose of reviewing reports 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) and making recommendations to the Secretary regarding the initial classification of devices under [section 360c(f)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/f/1&num=0&edition=prelim). (2) **Requirements regarding review** (A) *In general* — In making a recommendation to the Secretary under paragraph (1), an accredited person shall notify the Secretary in writing of the reasons for the recommendation. (B) *Time period for review* — Not later than 30 days after the date on which the Secretary is notified under subparagraph (A) by an accredited person with respect to a recommendation of an initial classification of a device, the Secretary shall make a determination with respect to the initial classification. (C) *Special rule* — The Secretary may change the initial classification under [section 360c(f)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360c/f/1&num=0&edition=prelim) that is recommended under paragraph (1) by an accredited person, and in such case shall provide to such person, and the person who submitted the report under [section 360(k) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360/k&num=0&edition=prelim) for the device, a statement explaining in detail the reasons for the change. (3) **Certain devices** (A) *In general* — An accredited

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21 U.S.C. § 379d–3 — Streamlined hiring authority

**(a) In general** In addition to any other personnel authorities under other provisions of law, the Secretary may, without regard to the provisions of title 5 governing appointments in the competitive service, appoint employees to positions in the Food and Drug Administration to perform, administer, or support activities described in subsection (b), if the Secretary determines that such appointments are needed to achieve the objectives specified in subsection (c). **(b) Activities described** The activities described in this subsection are— (1) activities under this chapter related to the process for the review of device applications (as defined in [section 379i(9) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379i/9&num=0&edition=prelim)); and (2) activities under this chapter related to human generic drug activities (as defined in [section 379j–41 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379j-41&num=0&edition=prelim)). **(c) Objectives specified** The objectives specified in this subsection are— (1) with respect to the activities under subsection (b)(1), the goals referred to in [section 379j–1(a)(1) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379j–1/a/1&num=0&edition=prelim); and (2) with respect to the activities under subsection (b)(2), the goals referred to in [section 379j–43(a) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section379j–43/a&num=0&edition=prelim). **(d) Internal controls** The Secretary shall institute appropriate internal controls for appointments under this section. **(e) Sunset** The authority to appoint employees under this section shall terminate on the dat

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21 U.S.C. § 379j–1 — Reauthorization; reporting requirements

**(a) Reports** (1) **Performance report** (A) *In general* (i) *General requirements* — Beginning with fiscal year 2023, for each fiscal year for which fees are collected under this subpart, the Secretary shall prepare and submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and Commerce of the House of Representatives annual reports concerning the progress of the Food and Drug Administration in achieving the goals identified in the letters described in section 201(b) 11 See References in Text note below. of the Medical Device User Fee Amendments of 2022 during such fiscal year and the future plans of the Food and Drug Administration for meeting the goals. (ii) *Additional information* — Beginning with fiscal year 2023, the annual report under this subparagraph shall include the progress of the Center for Devices and Radiological Health in achieving the goals, and future plans for meeting the goals, including— (I) the number of premarket applications filed under [section 360e of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360e&num=0&edition=prelim) per fiscal year for each review division; (II) the number of reports 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) per fiscal year for each review division; (III) the number of expedited development and priority review designations under section 360e–3 1 of this title per fiscal year; (IV) the number of investigational device exemption applications submitted under [section 360j(g) of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360j/g&num=0&

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21 U.S.C. § 379k–1 — Electronic format for submissions

**(a) Drugs and biologics** (1) **In general** — Beginning no earlier than 24 months after the issuance of a final guidance issued after public notice and opportunity for comment, submissions under subsection (b), (i), or (j) of [section 355 of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section355&num=0&edition=prelim) or subsection (a) or (k) of [section 262 of title 42](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title42-section262&num=0&edition=prelim) shall be submitted in such electronic format as specified by the Secretary in such guidance. (2) **Guidance contents** — In the guidance under paragraph (1), the Secretary may— (A) provide a timetable for establishment by the Secretary of further standards for electronic submission as required by such paragraph; and (B) set forth criteria for waivers of and exemptions from the requirements of this subsection. (3) **Exception** — This subsection shall not apply to submissions described in [section 360bbb of this title](https://uscode.house.gov/view.xhtml?req=granuleid:USC-prelim-title21-section360bbb&num=0&edition=prelim). **(b) Devices** (1) **In general** — Beginning after the issuance of final guidance implementing this paragraph, presubmissions and submissions for devices under section 360(k), 360c(f)(2)(A), 360e(c), 360e(d), 360e(f), 360j(g), 360j(m), or 360bbb–3 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), and any supplements to such presubmissions or submissions, shall include an electronic copy of such presubmissions or submissions. (2) **Guidance contents** — In the guidance under paragraph (1), the Secretary may— (A) provide standards for the

Source: Supplied U.S. Code snapshot — release unconfirmed · 21 U.S.C. § 379k–1

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