Statutes, codes, and regulations
Code of Federal Regulations
Title 21 - FOOD AND DRUGSChapter I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICESSubchapter H - MEDICAL DEVICESPart 822 - POSTMARKET SURVEILLANCE
Subpart E - RESPONSIBILITIES OF MANUFACTURERS
Section 822.24 - What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?

21 C.F.R. § 822.24

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Current through October 31, 2024
Section 822.24 - What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?

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.

21 C.F.R. §822.24

88 FR 16880 , Mar. 21, 2023
88 FR 16880 , 3/21/2023