Reference:USA 21 CFR Part 50 09-Apr-2025 § 812.36 (c)
From GxPlex
| Document information | |
|---|---|
| Reference | USA 21 CFR Part 50 09-Apr-2025 |
| Validity area | USA |
| Scope(s) | G |
| Document name | 21 CFR Part 50 |
| 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 A—General Part 50 Protection of Human Subjects 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 3.2.2 |
| Scope | G |
| Document part | § 812.36
(c) |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Compassionate use, Inclusion criteria, Investigational device, Medical device, FDA |
Content
§ 812.36 Treatment use of an investigational device. (c) Applications for treatment use. (1) A treatment IDE application shall include, in the following order: [...] (ii) The intended use of the device, the criteria for patient selection, and a written protocol describing the treatment use; [...]
