CFR section
21 CFR 812.36(e): Treatment use of an investigational device
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart B-Application and Administrative Action
Key facts
| Citation | 21 CFR 812.36(e) |
|---|---|
| Section | Treatment use of an investigational device |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart B-Application and Administrative Action |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, General |
| Regulation text (excerpt) | (e) Safeguards. Treatment use of an investigational device is conditioned upon the sponsor and investigators complying with the safeguards of the IDE process and the regulations governing informed consent (part 50 of this chapter) and institutional review boards (part 56 of this chapter). |
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.