CFR section
21 CFR 812.46(b)(1): Monitoring investigations
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart C-Responsibilities of Sponsors
Key facts
| Citation | 21 CFR 812.46(b)(1) |
|---|---|
| Section | Monitoring investigations |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart C-Responsibilities of Sponsors |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, General |
| Regulation text (excerpt) | (1) A sponsor shall immediately conduct an evaluation of any unanticipated adverse device effect. |
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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.