A study may not be needed in each pediatric subpopulation if data from one subpopulation can be extrapolated to another subpopulation.
21 U.S. Code § 360e–1 - Pediatric uses of devices
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.
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