---
kind: "section"
citation: "21 U.S.C. § 360e–3"
title: "21"
title_heading: "Food and Drugs"
number: "360e–3"
heading: "Breakthrough devices"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360e-3"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §360e–3. Breakthrough devices

- (a) **Purpose—** The purpose of this section is to encourage the [Secretary](/usc/21/321.md?p=d), and provide the [Secretary](/usc/21/321.md?p=d) with sufficient authority, to apply efficient and flexible approaches to expedite the development of, and prioritize the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration’s review of, [devices](/usc/21/321.md?p=h-1) that represent breakthrough technologies.
- (b) **Establishment of program—** The [Secretary](/usc/21/321.md?p=d) shall establish a program to expedite the development of, and provide for the priority review for, [devices](/usc/21/321.md?p=h-1), as determined by the [Secretary](/usc/21/321.md?p=d)—
  - (1) that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating human disease or conditions; and
  - (2)
    - (A) that represent breakthrough technologies;
    - (B) for which no approved or cleared alternatives exist;
    - (C) that offer significant advantages over existing approved or cleared alternatives, including the potential, compared to existing approved alternatives, to reduce or eliminate the need for hospitalization, improve patient quality of life, facilitate patients’ ability to manage their own care (such as through self-directed personal assistance), or establish long-term clinical efficiencies; or
    - (D) the availability of which is in the best interest of patients.
- (c) **Request for designation—** A [sponsor](/usc/21/360fff.md?p=8) of a [device](/usc/21/321.md?p=h-1) may request that the [Secretary](/usc/21/321.md?p=d) designate such [device](/usc/21/321.md?p=h-1) for expedited development and priority review under this section. Any such request for designation may be made at any time prior to the submission of an application under [section 360e(c) of this title](/usc/21/360e.md?p=c), a notification under [section 360(k) of this title](/usc/21/360.md?p=k), or a petition for classification under [section 360c(f)(2) of this title](/usc/21/360c.md?p=f-2).
- (d) **Designation process—**
  - (1) **In general—** Not later than 60 calendar days after the receipt of a request under [subsection (c)](#c), the [Secretary](/usc/21/321.md?p=d) shall determine whether the [device](/usc/21/321.md?p=h-1) that is the subject of the request meets the criteria described in [subsection (b)](#b). If the [Secretary](/usc/21/321.md?p=d) determines that the [device](/usc/21/321.md?p=h-1) meets the criteria, the [Secretary](/usc/21/321.md?p=d) shall designate the [device](/usc/21/321.md?p=h-1) for expedited development and priority review.
  - (2) **Review—** Review of a request under [subsection (c)](#c) shall be undertaken by a team that is composed of experienced staff and senior managers of the [Food](/usc/21/321.md?p=f) and [Drug](/usc/21/321.md?p=g-1) Administration.
  - (3) **Withdrawal—** The [Secretary](/usc/21/321.md?p=d) may not withdraw a designation granted under this section on the basis of the criteria under [subsection (b)](#b) no longer applying because of the subsequent clearance or approval of another [device](/usc/21/321.md?p=h-1) that—
    - (A) was designated under this section; or
    - (B) was given priority review under [section 360e(d)(5) of this title](/usc/21/360e.md?p=d-5), as in effect prior to December 13, 2016.
- (e) **Expedited development and priority review—**
  - (1) **Actions—** For purposes of expediting the development and review of [devices](/usc/21/321.md?p=h-1) designated under [subsection (d)](#d) the [Secretary](/usc/21/321.md?p=d) shall—
    - (A) assign a team of staff, including a team leader with appropriate subject matter expertise and experience, for each [device](/usc/21/321.md?p=h-1) for which a request is submitted under [subsection (c)](#c);
    - (B) provide for oversight of the team by senior agency personnel to facilitate the efficient development of the [device](/usc/21/321.md?p=h-1) and the efficient review of any submission described in [subsection (c)](#c) for the [device](/usc/21/321.md?p=h-1);
    - (C) adopt an efficient process for timely dispute resolution;
    - (D) provide for interactive and timely communication with the [sponsor](/usc/21/360fff.md?p=8) of the [device](/usc/21/321.md?p=h-1) during the development program and review process;
    - (E) expedite the [Secretary](/usc/21/321.md?p=d)’s review of manufacturing and quality systems compliance, as applicable;
    - (F) disclose to the [sponsor](/usc/21/360fff.md?p=8), not less than 5 business days in advance, the topics of any consultation the [Secretary](/usc/21/321.md?p=d) intends to undertake with external experts or an [advisory committee](/usc/21/360fff.md?p=1) concerning the [sponsor](/usc/21/360fff.md?p=8)’s [device](/usc/21/321.md?p=h-1) and provide the [sponsor](/usc/21/360fff.md?p=8) the opportunity to recommend such external experts;
    - (G) provide for [advisory committee](/usc/21/360fff.md?p=1) input, as the [Secretary](/usc/21/321.md?p=d) determines appropriate (including in response to the request of the [sponsor](/usc/21/360fff.md?p=8)) for applications submitted under [section 360e(c) of this title](/usc/21/360e.md?p=c); and
    - (H) assign staff to be available within a reasonable time to address questions by institutional review committees concerning the conditions and clinical testing requirements applicable to the investigational use of the [device](/usc/21/321.md?p=h-1) pursuant to an exemption under [section 360j(g) of this title](/usc/21/360j.md?p=g).
  - (2) **Additional actions—** In addition to the actions described in [paragraph (1)](#e-1), for purposes of expediting the development and review of [devices](/usc/21/321.md?p=h-1) designated under [subsection (d)](#d), the [Secretary](/usc/21/321.md?p=d), in collaboration with the [device](/usc/21/321.md?p=h-1) [sponsor](/usc/21/360fff.md?p=8), may, as appropriate—
    - (A) coordinate with the [sponsor](/usc/21/360fff.md?p=8) regarding early agreement on a data development plan;
    - (B) take steps to ensure that the design of clinical trials is as efficient and flexible as practicable, when scientifically appropriate;
    - (C) facilitate, when scientifically appropriate, expedited and efficient development and review of the [device](/usc/21/321.md?p=h-1) through utilization of timely postmarket data collection with regard to application for approval under [section 360e(c) of this title](/usc/21/360e.md?p=c); and
    - (D) agree in writing to clinical protocols that the [Secretary](/usc/21/321.md?p=d) will consider binding on the [Secretary](/usc/21/321.md?p=d) and the [sponsor](/usc/21/360fff.md?p=8), subject to—
      - (i) changes to such protocols agreed to in writing by the [sponsor](/usc/21/360fff.md?p=8) and the [Secretary](/usc/21/321.md?p=d); or
      - (ii) a decision, made by the director of the office responsible for reviewing the [device](/usc/21/321.md?p=h-1) submission, that a substantial scientific issue essential to determining the safety or effectiveness of such [device](/usc/21/321.md?p=h-1) exists, provided that such decision is in writing, and is made only after the [Secretary](/usc/21/321.md?p=d) provides to the [device](/usc/21/321.md?p=h-1) [sponsor](/usc/21/360fff.md?p=8) or applicant an opportunity for a meeting at which the director and the [sponsor](/usc/21/360fff.md?p=8) or applicant are present and at which the director documents the substantial scientific issue.
- (f) **Priority review guidance—**
  - (1) **Content—** Not later than 1 year after December 13, 2016, the [Secretary](/usc/21/321.md?p=d) shall issue guidance on the implementation of this section. Such guidance shall—
    - (A) set forth the process by which a [person](/usc/21/321.md?p=e) may seek a designation under [subsection (d)](#d);
    - (B) provide a template for requests under [subsection (c)](#c);
    - (C) identify the criteria the [Secretary](/usc/21/321.md?p=d) will use in evaluating a request for designation under this section; and
    - (D) identify the criteria and processes the [Secretary](/usc/21/321.md?p=d) will use to assign a team of staff, including team leaders, to review [devices](/usc/21/321.md?p=h-1) designated for expedited development and priority review, including any training required for such personnel to ensure effective and efficient review.
  - (2) **Process—** Prior to finalizing the guidance under [paragraph (1)](#f-1), the [Secretary](/usc/21/321.md?p=d) shall seek public comment on a draft version of that guidance.
- (g) **Rule of construction—** Nothing in this section shall be construed to affect—
  - (1) the criteria and standards for evaluating an application pursuant to [section 360e(c) of this title](/usc/21/360e.md?p=c), a report and request for classification under [section 360c(f)(2) of this title](/usc/21/360c.md?p=f-2), or a report under [section 360(k) of this title](/usc/21/360.md?p=k), including the recognition of valid scientific evidence as described in [section 360c(a)(3)(B) of this title](/usc/21/360c.md?p=a-3-B) and consideration and application of the least burdensome means of evaluating [device](/usc/21/321.md?p=h-1) effectiveness or demonstrating substantial equivalence between [devices](/usc/21/321.md?p=h-1) with differing technological characteristics, as applicable;
  - (2) the authority of the [Secretary](/usc/21/321.md?p=d) with respect to clinical holds under [section 360j(g)(8)(A) of this title](/usc/21/360j.md?p=g-8-A);
  - (3) the authority of the [Secretary](/usc/21/321.md?p=d) to act on an application pursuant to [section 360e(d) of this title](/usc/21/360e.md?p=d) before completion of an establishment inspection, as the [Secretary](/usc/21/321.md?p=d) determines appropriate; or
  - (4) the authority of the [Secretary](/usc/21/321.md?p=d) with respect to postmarket surveillance under sections [360i(h)](/usc/21/360i.md?p=h) and [360l](/usc/21/360l.md) of this title.

## Source credit

(June 25, 1938, ch. 675, § 515B, formerly § 515C, as added Pub. L. 114–255, div. A, title III, § 3051(a), Dec. 13, 2016, 130 Stat. 1121; renumbered § 515B and amended Pub. L. 115–52, title IX, § 901(f), (g), Aug. 18, 2017, 131 Stat. 1076, 1077.)

## Notes

### Editorial Notes

### Amendments

2017—Pub. L. 115–52, § 901(f)(1), made technical amendment to directory language of Pub. L. 114–255, § 3051(a), which added this section.

Subsec. (f)(2). Pub. L. 115–52, § 901(g), substituted “a draft version of that guidance” for “a proposed guidance”.

### Statutory Notes and Related Subsidiaries

### Effective Date of 2017 Amendment

Pub. L. 115–52, title IX, § 901(f), Aug. 18, 2017, 131 Stat. 1076, provided that the renumbering and amendment made by section 901(f) is effective as of the enactment of Pub. L. 114–255.