Maps to
21 CFR Part 822: §822.1 What does this part cover?, §822.4 Does this part apply to me?, §822.5 How will I know if I must conduct postmarket surveillance?, §822.8 When, where, and how must I submit my postmarket surveillance plan?, §822.9 What must I include in my submission?, §822.17 How long will your review of my submission take?, §822.19 What kinds of decisions may you make?, §822.24 What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?
Requirement text
FDA may order manufacturers to conduct postmarket surveillance of class II or class III devices when failure of the device would be reasonably likely to have serious adverse health consequences, the device is intended to be implanted for more than one year, the device is life-supporting or life-sustaining and used outside a user facility, or the device is expected to have significant use in pediatric populations. When ordered, manufacturers must submit a postmarket surveillance plan to FDA within 30 days of receiving the surveillance order. The plan must address the surveillance question identified in the order.
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