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).
The application or protocol described in paragraph (1) shall include, with respect to the device for which approval is sought and if readily available-
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-
For the items described in this paragraph, such report shall disaggregate the number of devices by pediatric subpopulation.
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.
A study may not be needed in each pediatric subpopulation if data from one subpopulation can be extrapolated to another 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.
21 U.S.C. § 360e-1
EDITORIAL NOTES
AMENDMENTS2017-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-"(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."