{"data":{"id":"us/21-cfr-801.116","jurisdiction":"us","citation":"21 CFR 801.116","heading":"Medical devices having commonly known directions.","body":"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.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"fc2f93687ed6e218046d959b73e91a8e590409ca4d21c6c763c75dd62835cdee","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-801.110","next":"us/21-cfr-801.119"},"notice":"GroundRules: Original legal text. Not legal advice."}