GroundRules
21 CFR 801.125: Medical devices for use in teaching, law enforcement, research, and analysis.
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 subject to § 801.109 shall be exempt from section 502(f)(1) of this act if shipped or sold to, or in the possession of, persons regularly and lawfully engaged in instruction in pharmacy, chemistry, or medicine not involving clinical use, or engaged in law enforcement, or in research not involving clinical use, or in chemical analysis, or physical testing, and is to be used only for such instruction, law enforcement, research, analysis, or testing.
Collected 2026-08-27T02:24:47Z. Source file · JSON