GroundRules
21 CFR 801.116: Medical devices having commonly known directions.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 801—LABELING
- Subpart D—Exemptions From Adequate Directions for Use
A device shall be exempt from section 502(f)(1) of the act insofar as adequate directions for common uses thereof are known to the ordinary individual.
Collected 2026-08-27T02:24:47Z. Source file · JSON