Reference:USA 21 CFR Part 812 09-Apr-2025 § 812.27
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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 2.1.4 |
| Scope | MD |
| Document part | § 812.27 |
| Language | EN |
| Original entry by | Florian Adragna |
| Contributors | |
| Tags | Medical device, Clinical data, Documentation, FDA |
| Comment | Report of prior investigations for device IDE |
Content
§ 812.27 Report of prior investigations. (a) General. The report of prior investigations shall include reports of all prior clinical, animal, and laboratory testing of the device and shall be comprehensive and adequate to justify the proposed investigation. (b) Specific contents. The report also shall include: [...]
