Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.30
From GxPlex
| Document information | |
|---|---|
| Reference | USA 21 CFR Part 812 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | MD |
| Document name | 21 CFR Part 812 |
| Version / Revision | 09-Apr-2025 |
| Status | Current |
| Document type | Legal act |
| Language(s) | EN |
| Description | Title 21 —Food and Drugs
Chapter I —Food and Drug Administration, Department of Health and Human Services Subchapter H—Medical Devices Part 812 Investigational Device Exemptions https://www.ecfr.gov/current/title-21 |
| Official source | Official link |
| Restricted access | No |
| Submitted by | Florian Adragna |
| Contributors | |
| Reference Details | |
|---|---|
| Module | Module 1 — Unit 1.5.4 |
| Scope | MD |
| Document part | § 812.30 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Regulatory submission, FDA, Sponsor, Medical device |
| Comment | FDA action on IDE applications |
Content
§ 812.30 FDA action on applications (a) Approval or disapproval. FDA will notify the sponsor in writing of the date it receives an application. FDA may approve an investigation as proposed, approve it with modifications, or disapprove it. An investigation may not begin until: (1) Thirty days after FDA receives the application at the address in § 812.19 for the investigation of a device other than a banned device, unless FDA notifies the sponsor that the investigation may not begin; or (2) FDA approves, by order, an IDE for the investigation.
(b) Grounds for disapproval or withdrawal […] (c) Notice of disapproval or withdrawal [...]
