CFR section
21 CFR 812.110(c): Specific responsibilities of investigators
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart E-Responsibilities of Investigators
Key facts
| Citation | 21 CFR 812.110(c) |
|---|---|
| Section | Specific responsibilities of investigators |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart E-Responsibilities of Investigators |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, General |
| Regulation text (excerpt) | (c) Supervising device use. An investigator shall permit an investigational device to be used only with subjects under the investigator's supervision. An investigator shall not supply an investigational device to any person not authorized under this part to receive it. |
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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.