---
kind: "section"
citation: "21 U.S.C. § 360e–1"
title: "21"
title_heading: "Food and Drugs"
number: "360e–1"
heading: "Pediatric uses of devices"
release: "119-102"
date: "2026-07-12"
url: "https://uscodex.org/usc/21/360e-1"
units:
  - "Chapter 9 — Federal Food, Drug, and Cosmetic Act"
  - "Subchapter V — Drugs and Devices"
  - "Part A — Drugs and Devices"
---

# §360e–1. Pediatric uses of devices

- (a) **New devices—**
  - (1) **In general—** A [person](/usc/21/321.md?p=e) that submits to the [Secretary](/usc/21/321.md?p=d) an application under [section 360j(m) of this title](/usc/21/360j.md?p=m), or an application (or supplement to an application) or a [product](/usc/21/360eee.md?p=13) development protocol under [section 360e of this title](/usc/21/360e.md), shall include in the application or protocol the information described in [paragraph (2)](#a-2).
  - (2) **Required information—** The application or protocol described in [paragraph (1)](#a-1) shall include, with respect to the [device](/usc/21/321.md?p=h-1) for which approval is sought and if readily available—
    - (A) a description of any pediatric subpopulations that suffer from the disease or condition that the [device](/usc/21/321.md?p=h-1) is intended to treat, diagnose, or cure; and
    - (B) the number of affected pediatric patients.
  - (3) **Annual report—** Not later than 18 months after September 27, 2007, and annually thereafter, the [Secretary](/usc/21/321.md?p=d) shall submit to the Committee on Health, Education, Labor, and Pensions of the Senate and the Committee on Energy and [Commerce](/usc/21/360hh.md?p=4) of the House of Representatives a report that includes—
    - (A) the number of [devices](/usc/21/321.md?p=h-1) approved in the year preceding the year in which the report is submitted, for which there is a pediatric subpopulation that suffers from the disease or condition that the [device](/usc/21/321.md?p=h-1) is intended to treat, diagnose, or cure;
    - (B) any information, based on a review of data available to the [Secretary](/usc/21/321.md?p=d), regarding [devices](/usc/21/321.md?p=h-1) used in pediatric patients but not labeled for such use for which the [Secretary](/usc/21/321.md?p=d) determines that approved pediatric [labeling](/usc/21/321.md?p=m) could confer a benefit to pediatric patients;
    - (C) the number of pediatric [devices](/usc/21/321.md?p=h-1) that receive a humanitarian use exemption under [section 360j(m) of this title](/usc/21/360j.md?p=m);
    - (D) the number of [devices](/usc/21/321.md?p=h-1) approved in the year preceding the year in which the report is submitted, labeled for use in pediatric patients;
    - (E) the number of pediatric [devices](/usc/21/321.md?p=h-1) approved in the year preceding the year in which the report is submitted, exempted from a fee pursuant to [section 379j(a)(2)(B)(v) of this title](/usc/21/379j.md?p=a-2-B-v);
    - (F) the review time for each [device](/usc/21/321.md?p=h-1) described in subparagraphs [(A)](#a-3-A), [(C)](#a-3-C), [(D)](#a-3-D), and [(E)](#a-3-E);
    - (G) the number of [devices](/usc/21/321.md?p=h-1) for which the [Secretary](/usc/21/321.md?p=d) relied on data with respect to adults to support a determination of a reasonable assurance of safety and effectiveness in pediatric patients; and
    - (H) the number of [devices](/usc/21/321.md?p=h-1) for which the [Secretary](/usc/21/321.md?p=d) relied on data from one pediatric subpopulation to support a determination of a reasonable assurance of safety and effectiveness in another pediatric subpopulation.

  For the items described in this paragraph, such report shall disaggregate the number of [devices](/usc/21/321.md?p=h-1) by pediatric subpopulation.

- (b) **Determination of pediatric effectiveness based on similar course of disease or condition or similar effect of device on adults—**
  - (1) **In general—** If the course of the disease or condition and the effects of the [device](/usc/21/321.md?p=h-1) are sufficiently similar in adults and pediatric patients, the [Secretary](/usc/21/321.md?p=d) may conclude that adult data may be used to support a determination of a reasonable assurance of effectiveness in pediatric populations, as appropriate.
  - (2) **Extrapolation between subpopulations—** A study may not be needed in each pediatric subpopulation if data from one subpopulation can be extrapolated to another subpopulation.
- (c) **Pediatric subpopulation—** For purposes of this section, the term “pediatric subpopulation” has the meaning given the term in [section 360j(m)(6)(E)(ii) of this title](/usc/21/360j.md?p=m-6-E-ii).

## Source credit

(June 25, 1938, ch. 675, § 515A, as added Pub. L. 110–85, title III, § 302, Sept. 27, 2007, 121 Stat. 859; amended Pub. L. 115–52, title V, § 502(a), Aug. 18, 2017, 131 Stat. 1037.)

## Notes

### Editorial Notes

### Amendments

2017—Subsec. (a)(3). Pub. L. 115–52 added subpars. (B), (C), (G), and (H), redesignated former subpars. (B) to (D) as (D) to (F), respectively, substituted “(C), (D), and (E);” for “(B), and (C).” in subpar. (F), and inserted concluding provisions.

### Statutory Notes and Related Subsidiaries

### Final Rule Relating to Tracking of Pediatric Uses of Devices

Pub. L. 112–144, title VI, § 620(b), July 9, 2012, 126 Stat. 1064, provided that: “The Secretary of Health and Human Services shall issue— a proposed rule implementing section 515A(a)(2) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360e–1(a)(2)) not later than December 31, 2012; and a final rule implementing such section not later than December 31, 2013.”