Pub. L. 114-255, div. A, tit. III, subtit. F, sec. 3056 (as amended)
INSTITUTIONAL REVIEW BOARD FLEXIBILITY.
SEC. 3056. INSTITUTIONAL REVIEW BOARD FLEXIBILITY.
Section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) is amended—
(1) in subsection (g)(3)—
(A) in subparagraph (A)(i)—
(i) by striking “local”; and
(ii) by striking “which has been”; and
(B) in subparagraph (B), by striking “a local institutional” and inserting “an institutional”; and
(2) in subsection (m)(4)—
(A) by striking subparagraph (A) and inserting the following:
“(A) in facilities in which clinical testing of devices is supervised by an institutional review committee established in accordance with the regulations of the Secretary; and”
;
(B) in subparagraph (B), by striking “a local institutional” and inserting “an institutional”; and
(C) in the matter following subparagraph (B), by striking “local”.