21 CFR 822.24 - What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

View all text of Subpart E [§ 822.24 - § 822.28]

§ 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.

[88 FR 16880, Mar. 21, 2023]

authority: 21 U.S.C. 331,352,360i,360l,371,374

source: 67 FR 38887, June 6, 2002, unless otherwise noted.

cite as: 21 CFR 822.24