View all text of Part E [§ 360bbb - § 360bbb-8d]
§ 360bbb–8b. Use of clinical investigation data from outside the United States
(a) In general
(b) Notice to sponsor
(June 25, 1938, ch. 675, § 569B, as added Pub. L. 112–144, title XI, § 1123, July 9, 2012, 126 Stat. 1113; amended Pub. L. 114–255, div. A, title III, § 3101(a)(2)(Q), Dec. 13, 2016, 130 Stat. 1155.)