Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (2)
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 6 — Unit 6.1.2 |
| Scope | MD |
| Document part | § 812.150
(a) (2) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Withdrawal of ethics approval, Investigator safety reporting, Interim report, Medical device, FDA |
Content
§ 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:
(2) Withdrawal of IRB approval. An investigator shall report to the sponsor, within 5 working days, a withdrawal of approval by the reviewing IRB of the investigator's part of an investigation. [...]
