CFR section
21 CFR 812.110(a): Specific responsibilities of investigators
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart E-Responsibilities of Investigators
Key facts
| Citation | 21 CFR 812.110(a) |
|---|---|
| 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) | (a) Awaiting approval. An investigator may determine whether potential subjects would be interested in participating in an investigation, but shall not request the written informed consent of any subject to participate, and shall not allow any subject to participate before obtaining IRB and FDA approval. |
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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.