Agency documentation and review of significant decisions regarding devices

21 U.S. Code § 360g-1. Agency documentation and review of significant decisions regarding devices

(a) Documentation of rationale for significant decisions
(1) In general
The Secretary shall provide a substantive summary of the scientific and regulatory rationale for any significant decision of the Center for Devices and Radiological Health regarding submission or review of a report under section 360(k) of this title, a petition for classification under section 360c(f) of this title, an application under section 360e of this title, or an application for an exemption under section 360j(g) of this title, including documentation of significant controversies or differences of opinion and the resolution of such controversies or differences of opinion.
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