View all text of Part A [§ 351 - § 360n-2]
§ 360g–1. Agency documentation and review of significant decisions regarding devices
(a) Documentation of rationale for significant decisions
(1) In general
(2) Provision of documentation
(3) Application of least burdensome requirements
(b) Review of significant decisions
(1) Request for supervisory review of significant decision
(2) Submission of request
(3) Timeframe
(A) In general
(B) Exception
(June 25, 1938, ch. 675, § 517A, as added Pub. L. 112–144, title VI, § 603, July 9, 2012, 126 Stat. 1051; amended Pub. L. 114–255, div. A, title III, §§ 3051(b), 3058(c), Dec. 13, 2016, 130 Stat. 1124, 1129;