CFR section
21 CFR 812.40: General responsibilities of sponsors
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart C-Responsibilities of Sponsors
Key facts
| Citation | 21 CFR 812.40 |
|---|---|
| Section | General responsibilities of sponsors |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart C-Responsibilities of Sponsors |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, General |
| Regulation text (excerpt) | Sponsors are responsible for selecting qualified investigators and providing them with the information they need to conduct the investigation properly, ensuring proper monitoring of the investigation, ensuring that IRB review and approval are obtained, submitting an IDE application to FDA, and ensuring that any reviewing IRB and FDA are promptly informed of significant new information about an investigation. Additional responsibilities of sponsors are described in subparts B and G. |
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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.