21 CFR 812.42 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Investigational Device Exemptions (§ 812.1 To § 812.150) — Responsibilities Of Sponsors (§ 812.40 To § 812.47) — FDA and IRB approval.

4 Aug 2016

A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation.

21 CFR 812.42
[46 FR 8957, Jan. 27, 1981]