Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.35
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| 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 4 — Unit 4.4.0 |
| Scope | MD |
| Document part | § 812.35 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Substantial modification, Amendment, Ethics committee, Medical device, FDA |
| Comment | IDE supplemental applications: changes requiring prior approval |
Content
§ 812.35 Supplemental applications (a) Changes in investigational plan — (1) Changes requiring prior approval […] (2) Changes effected for emergency use […] (3) Changes effected with notice to FDA within 5 days. […] (4) Changes submitted in annual report [...] (b) IRB approval for new facilities [...]
