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§ 822.10 - What must I include in my surveillance plan?

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Your surveillance plan must include a discussion of:

The plan objective(s) addressing the surveillance question(s) identified in our order;

The subject of the study, e.g., patients, the device, animals;

The variables and endpoints that will be used to answer the surveillance question, e.g., clinical parameters or outcomes;

The surveillance approach or methodology to be used;

Sample size and units of observation;

The investigator agreement, if applicable;

Sources of data, e.g., hospital records;

The data collection plan and forms;

The consent document, if applicable;

Institutional Review Board information, if applicable;

The patient followup plan, if applicable;

The procedures for monitoring conduct and progress of the surveillance;

An estimate of the duration of surveillance;

All data analyses and statistical tests planned;

The content and timing of reports.

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§ 822.9 - What must I include in my submission?
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§ 822.11 - What should I consider when designing my plan to conduct postmarket surveillance?