Reference:USA 21 CFR Part 812 09-Apr-2025 Subpart G
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 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 | |
|---|---|
| Module | Module 2 â Unit 2.1.2 |
| Scope | MD |
| Document part | Subpart G |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Documentation, Investigator record retention, Sponsor record retention, Medical device, FDA |
| Comment | Investigator and sponsor records for device investigations |
Content
Subpart GâRecords and Reports § 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: [âŚ] (b) Sponsor records. A sponsor shall maintain the following accurate, complete, and current records relating to an investigation: [...]
