Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.43 (c) (4)
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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 2 — Unit 2.3.1 |
| Scope | MD |
| Document part | § 812.43
(c) (4) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigator responsibilities, FDA, Ethics committee, Medical device, Written agreement |
Content
§ 812.43 Selecting investigators and monitors. […] (4) A statement of the investigator's commitment to: (i) Conduct the investigation in accordance with the agreement, the investigational plan, this part and other applicable FDA regulations, and conditions of approval imposed by the reviewing IRB or FDA; (ii) Supervise all testing of the device involving human subjects; and (iii) Ensure that the requirements for obtaining informed consent are met. [...]
