GroundRules
21 CFR 822.28: If I stop marketing the device subject to postmarket surveillance, what must I do?
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 822—POSTMARKET SURVEILLANCE
- Subpart E—Responsibilities of Manufacturers
You must continue to conduct postmarket surveillance in accordance with your approved plan even if you no longer market the device. You may request that we allow you to terminate postmarket surveillance or modify your postmarket surveillance because you no longer market the device. We will make these decisions on a case-by-case basis, and you must continue to conduct the postmarket surveillance unless we notify you that you may stop your surveillance study.
Collected 2026-08-27T02:24:47Z. Source file · JSON