Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.7 (c)
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 —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 5.4.3 |
| Scope | MD |
| Document part | § 812.7
(c) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Investigational device, Sponsor, Medical device, FDA |
Content
§ 812.7 Prohibition of promotion and other practices. A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not: […] (c) Unduly prolong an investigation. If data developed by the investigation indicate in the case of a class III device that premarket approval cannot be justified or in the case of a class II device that it will not comply with an applicable performance standard or an amendment to that standard, the sponsor shall promptly terminate the investigation.
