Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart D
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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 âFood and Drugs
Chapter I âFood and Drug Administration, Department of Health and Human Services Subchapter HâMedical 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 | |
|---|---|
| Scope | MD |
| Document part | Subpart D |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags (EN) | |
| Tags (original language) | |
| Tags (FR) | |
| Comment | IRB composition, duties and functions for device investigations |
Content
Subpart DâIRB Review and Approval § 812.60 IRB composition, duties, and functions. An IRB reviewing and approving investigations under this part shall comply with the requirements of part 56 in all respects, including its composition, duties, and functions.
§ 812.62 IRB approval. (a) An IRB shall review and have authority to approve, require modifications in (to secure approval), or disapprove all investigations covered by this part. (b) If no IRB exists or if FDA finds that an IRB's review is inadequate, a sponsor may submit an application to FDA.
§ 812.64 IRB's continuing review. The IRB shall conduct its continuing review of an investigation in accordance with part 56. [...] § 812.66 Significant risk device determinations. [...]
