CFR section
21 CFR 812.110(b): Specific responsibilities of investigators
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart E-Responsibilities of Investigators
Key facts
| Citation | 21 CFR 812.110(b) |
|---|---|
| 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, Drugs, General |
| Regulation text (excerpt) | (b) Compliance. An investigator shall conduct an investigation in accordance with the signed agreement with the sponsor, the investigational plan, this part and other applicable FDA regulations, and any conditions of approval imposed by an IRB or FDA. |
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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.