CFR section
21 CFR 812.43(b): Selecting investigators and monitors
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart C-Responsibilities of Sponsors
Key facts
| Citation | 21 CFR 812.43(b) |
|---|---|
| Section | Selecting investigators and monitors |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart C-Responsibilities of Sponsors |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (b) Control of device. A sponsor shall ship investigational devices only to qualified investigators participating in the investigation. |
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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.