GroundRules
21 CFR 812.66: Significant risk device determinations.
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
If an IRB determines that an investigation, presented for approval under § 812.2(b)(1)(ii), involves a significant risk device, it shall so notify the investigator and, where appropriate, the sponsor. A sponsor may not begin the investigation except as provided in § 812.30(a).
Collected 2026-08-27T02:24:47Z. Source file · JSON