21 C.F.R. § 812.42 FDA and IRB approval.
Title 21 - Food and Drugs
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. [46 FR 8957, Jan. 27, 1981]
Title 21: Food and Drugs
PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
Subpart C—Responsibilities of Sponsors
§ 812.42 FDA and IRB approval.
