21 U.S. Code § 360e–1 - Pediatric uses of devices

(a) New devices
(1) In general
A person that submits to the Secretary an application under section 360j (m) of this title, or an application (or supplement to an application) or a product development protocol under section 360e of this title, shall include in the application or protocol the information described in paragraph (2).
(2) Required information
The application or protocol described in paragraph (1) shall include, with respect to the device 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 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 shall 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 a report that includes—
(A) the number of devices 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 is intended to treat, diagnose, or cure;
(B) the number of devices approved in the year preceding the year in which the report is submitted, labeled for use in pediatric patients;
(C) the number of pediatric devices 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; and
(D) the review time for each device described in subparagraphs (A), (B), and (C).
(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 are sufficiently similar in adults and pediatric patients, the Secretary 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.

Source

(June 25, 1938, ch. 675, § 515A, as added Pub. L. 110–85, title III, § 302,Sept. 27, 2007, 121 Stat. 859.)
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—
“(1) 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
“(2) a final rule implementing such section not later than December 31, 2013.”

This is a list of parts within the Code of Federal Regulations for which this US Code section provides rulemaking authority.

This list is taken from the Parallel Table of Authorities and Rules provided by GPO [Government Printing Office].

It is not guaranteed to be accurate or up-to-date, though we do refresh the database weekly. More limitations on accuracy are described at the GPO site.


21 CFR - Food and Drugs

21 CFR Part 3 - PRODUCT JURISDICTION

21 CFR Part 4 - REGULATION OF COMBINATION PRODUCTS

21 CFR Part 5 - ORGANIZATION

21 CFR Part 7 - ENFORCEMENT POLICY

21 CFR Part 10 - ADMINISTRATIVE PRACTICES AND PROCEDURES

21 CFR Part 11 - ELECTRONIC RECORDS; ELECTRONIC SIGNATURES

21 CFR Part 12 - FORMAL EVIDENTIARY PUBLIC HEARING

21 CFR Part 13 - PUBLIC HEARING BEFORE A PUBLIC BOARD OF INQUIRY

21 CFR Part 14 - PUBLIC HEARING BEFORE A PUBLIC ADVISORY COMMITTEE

21 CFR Part 15 - PUBLIC HEARING BEFORE THE COMMISSIONER

21 CFR Part 16 - REGULATORY HEARING BEFORE THE FOOD AND DRUG ADMINISTRATION

21 CFR Part 20 - PUBLIC INFORMATION

21 CFR Part 25 - ENVIRONMENTAL IMPACT CONSIDERATIONS

21 CFR Part 26 - MUTUAL RECOGNITION OF PHARMACEUTICAL GOOD MANUFACTURING PRACTICE REPORTS, MEDICAL DEVICE QUALITY SYSTEM AUDIT REPORTS, AND CERTAIN...DEVICE PRODUCT EVALUATION REPORTS: UNITED STATES AND THE EUROPEAN COMMUNITY

21 CFR Part 50 - PROTECTION OF HUMAN SUBJECTS

21 CFR Part 54 - FINANCIAL DISCLOSURE BY CLINICAL INVESTIGATORS

21 CFR Part 56 - INSTITUTIONAL REVIEW BOARDS

21 CFR Part 58 - GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES

21 CFR Part 71 - COLOR ADDITIVE PETITIONS

21 CFR Part 310 - NEW DRUGS

21 CFR Part 570 - FOOD ADDITIVES

21 CFR Part 571 - FOOD ADDITIVE PETITIONS

21 CFR Part 812 - INVESTIGATIONAL DEVICE EXEMPTIONS

21 CFR Part 814 - PREMARKET APPROVAL OF MEDICAL DEVICES

21 CFR Part 1010 - PERFORMANCE STANDARDS FOR ELECTRONIC PRODUCTS: GENERAL

21 CFR Part 1020 - PERFORMANCE STANDARDS FOR IONIZING RADIATION EMITTING PRODUCTS

21 CFR Part 1030 - PERFORMANCE STANDARDS FOR MICROWAVE AND RADIO FREQUENCY EMITTING PRODUCTS

21 CFR Part 1040 - PERFORMANCE STANDARDS FOR LIGHT-EMITTING PRODUCTS

21 CFR Part 1050 - PERFORMANCE STANDARDS FOR SONIC, INFRASONIC, AND ULTRASONIC RADIATION-EMITTING PRODUCTS

 

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