21 CFR §822.10

1. (a)The plan objective(s) addressing the surveillance question(s) identified in our order;
2. (b)The subject of the study, e.g., patients, the device, animals;
3. (c)The variables and endpoints that will be used to answer the surveillance question, e.g., clinical parameters or outcomes;
4. (d)The surveillance approach or methodology to be used;
5. (e)Sample size and units of observation;
6. (f)The investigator agreement, if applicable;
7. (g)Sources of data, e.g., hospital records;
8. (h)The data collection plan and forms;
9. (i)The consent document, if applicable;
10. (j)Institutional Review Board information, if applicable;
11. (k)The patient followup plan, if applicable;
12. (l)The procedures for monitoring conduct and progress of the surveillance;
13. (m)An estimate of the duration of surveillance;
14. (n)All data analyses and statistical tests planned;
15. (o)The content and timing of reports.