Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (b) (8)
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 3 — Unit 3.1.1 |
| Scope | MD |
| Document part | § 812.150
(b) (8) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Sponsor safety reporting, Informed consent, Sponsor, Medical device, FDA |
Content
§ 812.150 Reports. (b) Sponsor reports [...] (8) Informed consent. A sponsor shall submit to FDA a copy of any report by an investigator under paragraph (a)(5) of this section of use of a device without obtaining informed consent, within 5 working days of receipt of notice of such use. [...]
