CFR section
21 CFR 812.2(c)(7): Applicability
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 812.2(c)(7) |
|---|---|
| Section | Applicability |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (7) A custom device as defined in § 812.3(b), unless the device is being used to determine safety or effectiveness for commercial distribution. |
At a glance
- 1–9 Inspections citing this section
- None 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.