INFORMED CONSENT WAIVER OR ALTERATION FOR CLINICAL INVESTIGATIONS.

SEC. 3024. INFORMED CONSENT WAIVER OR ALTERATION FOR CLINICAL INVESTIGATIONS. (a) Devices.—Section 520(g)(3) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j(g)(3)) is amended— (1) in subparagraph (D), by striking “except where subject to such conditions as the Secretary may prescribe, the investigator” and inserting the following:“except where, subject to such conditions as the Secretary may prescribe— “(i) the proposed clinical testing poses no more than minimal risk to the human subject and includes appropriate safeguards to protect the rights, safety, and welfare of the human subject; or “(ii) the investigator” ; and (2) in the matter following subparagraph (D), by striking “subparagraph (D)” and inserting “subparagraph (D)(ii)”. (b) Drugs.—Section 505(i)(4) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 355(i)(4)) is amended by striking “except where it is not feasible or it is contrary to the best interests of such human beings” and inserting “except where it is not feasible, it is contrary to the best interests of such human beings, or the proposed clinical testing poses no more than minimal risk to such human beings and includes appropriate safeguards as prescribed to protect the rights, safety, and welfare of such human beings”.