Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.140 (a) (2)
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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 3.4.2 |
| Scope | MD |
| Document part | § 812.140
(a) (2) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Drug accountability, Investigational device, Documentation, Medical device, Investigator responsibilities |
Content
§ 812.140 Records. […] (a) Investigator records. A participating investigator shall maintain the following accurate, complete, and current records relating to the investigator's participation in an investigation: [...] (2) Records of receipt, use or disposition of a device that relate to: (i) The type and quantity of the device, the dates of its receipt, and the batch number or code mark. (ii) The names of all persons who received, used, or disposed of each device. (iii) Why and how many units of the device have been returned to the sponsor, repaired, or otherwise disposed of. [...]
