CFR section
21 CFR 812.25(e): Investigational plan
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart B-Application and Administrative Action
Key facts
| Citation | 21 CFR 812.25(e) |
|---|---|
| Section | Investigational plan |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart B-Application and Administrative Action |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, General |
| Regulation text (excerpt) | (e) Monitoring procedures. The sponsor's written procedures for monitoring the investigation and the name and address of any monitor. |
At a glance
- 10–99 Inspections citing this section
- 1–9 Warning letters citing this section
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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.