CFR section
21 CFR 812.7(b): Prohibition of promotion and other practices
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 812.7(b) |
|---|---|
| Section | Prohibition of promotion and other practices |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, General |
| Regulation text (excerpt) | (b) Commercialize an investigational device by charging the subjects or investigators for a device a price larger than that necessary to recover costs of manufacture, research, development, and handling. |
At a glance
- 1–9 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.