CFR section
21 CFR 860.7(g)(2): Determination of safety and effectiveness
PART 860-MEDICAL DEVICE CLASSIFICATION PROCEDURES · Subpart A-General
Key facts
| Citation | 21 CFR 860.7(g)(2) |
|---|---|
| Section | Determination of safety and effectiveness |
| Part | PART 860-MEDICAL DEVICE CLASSIFICATION PROCEDURES |
| Subpart | Subpart A-General |
| Subchapter | 21 CFR H Medical Devices |
| Product types cited | Devices |
| Regulation text (excerpt) | (2) The Commissioner may require that a manufacturer, importer, or distributor make reports or provide other information bearing on the classification of a device and indicating whether there is reasonable assurance of the safety and effectiveness of the device or whether it is adulterated or misbranded under the Federal Food, Drug, and Cosmetic Act. |
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.