CFR section
21 CFR 812.66: Significant risk device determinations
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart D-IRB Review and Approval
Key facts
| Citation | 21 CFR 812.66 |
|---|---|
| Section | Significant risk device determinations |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart D-IRB Review and Approval |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, General |
| Regulation text (excerpt) | 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). |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.