GroundRules
21 CFR 812.62: IRB approval.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS
- Subpart D—IRB Review and Approval
(a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all investigations covered by this part.
(b) If no IRB exists or if FDA finds that an IRB's review is inadequate, a sponsor may submit an application to FDA.
Collected 2026-08-27T02:24:47Z. Source file · JSON