CFR section
21 CFR 812.140(b)(4): Records
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart G-Records and Reports
Key facts
| Citation | 21 CFR 812.140(b)(4) |
|---|---|
| Section | Records |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart G-Records and Reports |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, General |
| Regulation text (excerpt) | (4) For each investigation subject to § 812.2(b)(1) of a device other than a significant risk device, the records described in paragraph (b)(5) of this section and the following records, consolidated in one location and available for FDA inspection and copying: (i) The name and intended use of the device and the objectives of the investigation; (ii) A brief explanation of why the device is not a significant risk device: (iii) The name and address of each investigator: (iv) The name and address… |
At a glance
- 1–9 Inspections citing this section
- 1–9 Warning letters citing this section
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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.