Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.150 (a) (1)
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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 5 — Unit 5.2.4 |
| Scope | MD |
| Document part | § 812.150
(a) (1) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator safety reporting, Unanticipated device effect, Ethics committee, Sponsor, Medical device |
Content
§ 812.150 Reports. (a) Investigator reports. An investigator shall prepare and submit the following complete, accurate, and timely reports:
(1) Unanticipated adverse device effects. An investigator shall submit to the sponsor and to the reviewing IRB a report of any unanticipated adverse device effect occurring during an investigation as soon as possible, but in no event later than 10 working days after the investigator first learns of the effect. [...]
