21 U.S.C. § 360e: Pediatric uses of devices

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). a description of any pediatric subpopulations that suffer from the disease or condition that the device is intended to treat, diagnose, or cure; and the number of affected pediatric patients. 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; any information, based on a review of data available to the Secretary, regarding devices used in pediatric patients but not labeled for such use for which the Secretary determines that approved pediatric labeling could confer a benefit to pediatric patients; the number of pediatric devices that receive a humanitarian use exemption under section 360j(m) of this title ; the number of devices approved in the year preceding the year in which the report is submitted, labeled for use in pediatric patients; 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 ; the review time for each device described in subparagraphs (A), (C), (D), and (E); the number of devices for which the Secretary relied on data with respect to adults to support a determination of a reasonable assurance of safety and effectiveness in pediatric patients; and the number of devices for which the Secretary relied on data from one pediatric subpopulation to support a determination of a reasonable assurance of safety and effectiveness in another 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 . 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 .”