CFR section
21 CFR 812.2(c): Applicability
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 812.2(c) |
|---|---|
| Section | Applicability |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, Drugs |
| Regulation text (excerpt) | (c) Exempted investigations. This part, with the exception of § 812.119, does not apply to investigations of the following categories of devices: (1) A device, other than a transitional device, in commercial distribution immediately before May 28, 1976, when used or investigated in accordance with the indications in labeling in effect at that time. (2) A device, other than a transitional device, introduced into commercial distribution on or after May 28, 1976, that FDA has determined to be… |
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.