CFR section
21 CFR 812.140(a)(3)(ii): Records
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart G-Records and Reports
Key facts
| Citation | 21 CFR 812.140(a)(3)(ii) |
|---|---|
| Section | Records |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart G-Records and Reports |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs, General |
| Regulation text (excerpt) | (ii) All relevant observations, including records concerning adverse device effects (whether anticipated or unanticipated), information and data on the condition of each subject upon entering, and during the course of, the investigation, including information about relevant previous medical history and the results of all diagnostic tests. |
At a glance
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.