Maps to
21 CFR Part 822: §822.3 How do you define the terms used in this part?, §822.10 What must I include in my surveillance plan?, §822.11 What should I consider when designing my plan to conduct postmarket surveillance?, §822.15 How long must I conduct postmarket surveillance of my device?, §822.21 What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?, §822.31 What records am I required to keep?
Requirement text
A postmarket surveillance plan submitted under Part 822 must include: the plan objective(s) addressing the surveillance question(s), the subject of the study, the variables and endpoints used to answer the surveillance question, the surveillance approach or methodology, sample size and units of observation, investigator agreements if applicable, data sources, the data collection plan and forms, consent documents and IRB information if applicable, patient followup plan if applicable, monitoring procedures, estimated duration, data analyses and statistical tests planned, and the content and timing of reports. FDA may order prospective surveillance for up to 36 months; longer periods require manufacturer agreement.
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