CFR section
21 CFR 812.2(c)(3): Applicability
PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS · Subpart A-General Provisions
Key facts
| Citation | 21 CFR 812.2(c)(3) |
|---|---|
| Section | Applicability |
| Part | PART 812-INVESTIGATIONAL DEVICE EXEMPTIONS |
| Subpart | Subpart A-General Provisions |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices, General |
| Regulation text (excerpt) | (3) A diagnostic device, if the sponsor complies with applicable requirements in § 809.10(c) and if the testing: (i) Is noninvasive, (ii) Does not require an invasive sampling procedure that presents significant risk, (iii) Does not by design or intention introduce energy into a subject, and (iv) Is not used as a diagnostic procedure without confirmation of the diagnosis by another, medically established diagnostic product or procedure. |
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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.