CFR section
21 CFR 812.36(d): Treatment use of an investigational device
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart B-Application and Administrative Action
Key facts
| Citation | 21 CFR 812.36(d) |
|---|---|
| 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) | (d) FDA action on treatment IDE applications - (1) Approval of treatment IDE's. Treatment use may begin 30 days after FDA receives the treatment IDE submission at the address specified in § 812.19, unless FDA notifies the sponsor in writing earlier than the 30 days that the treatment use may or may not begin. FDA may approve the treatment use as proposed or approve it with modifications. (2) Disapproval or withdrawal of approval of treatment IDE's. FDA may disapprove or withdraw approval of a… |
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.