Studies a U.S. FDA-regulated Device Product

(38) Studies a U.S. FDA-regulated Device Product means that a clinical trial studies a device product subject to section 510(k), 515, or 520(m) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360(k), 21 U.S.C. 360e, 21 U.S.C. 360j(m)).

Source

42 CFR § 11.10

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Scoping language

The following definitions apply to terms used in this part:

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