Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (5)
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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 3 — Unit 3.1.1 |
| Scope | MD |
| Document part | § 812.150
(a) (5) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator safety reporting, Informed consent, Sponsor, Medical device, FDA |
Content
§ 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:
(5) Informed consent. If an investigator uses a device without obtaining informed consent, the investigator shall report such use to the sponsor and the reviewing IRB within 5 working days after the use occurs. [...]
