21 CFR § 801.116 - Medical devices having commonly known directions.

---
identifier: "/us/cfr/t21/s801.116"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 801.116 - Medical devices having commonly known directions."
title_number: 21
title_name: "Food and Drugs"
section_number: "801.116"
section_name: "Medical devices having commonly known directions."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "801"
part_name: "LABELING"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 321, 331-334, 351, 352, 360d, 360i, 360j, 371, 374."
regulatory_source: "41 FR 6896, Feb. 13, 1976, unless otherwise noted."
cfr_part: "801"
---


# 801.116 Medical devices having commonly known directions.

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.