A study may not be needed in each pediatric subpopulation if data from one subpopulation can be extrapolated to another subpopulation.
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21 U.S. Code § 360e–1 - Pediatric uses of devices
(a) New devices
(1) In general
(2) Required informationThe application or protocol described in paragraph (1) shall include, with respect to the device for which approval is sought and if readily available—
(3) Annual reportNot 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—
the number of devices approved in the year preceding the year in which the report is submitted, labeled for use in pediatric patients;
the review time for each device described in subparagraphs (A), (C), (D), and (E);
(b) Determination of pediatric effectiveness based on similar course of disease or condition or similar effect of device on adults
(1) In general
(2) Extrapolation between subpopulations
(c) Pediatric subpopulation
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