GroundRules
21 CFR 822.24: What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?
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 submit your plan to conduct postmarket surveillance to us within 30 days from receipt of the order (letter) notifying you that you are required to conduct postmarket surveillance of a device. The manufacturer shall commence surveillance not later than 15 months after the day the order was issued.
Collected 2026-08-27T02:24:47Z. Source file · JSON