CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS > SUBPART C—Responsibilities of Sponsors (§812.40 to §812.47) > 812.42—FDA and IRB approval.

812.42—FDA and IRB approval.

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.

Code of Federal Regulations

[46 FR 8957, Jan. 27, 1981]