21 C.F.R. § 822.10 : Food and Drugs — FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES — MEDICAL DEVICES — POSTMARKET SURVEILLANCE — POSTMARKET SURVEILLANCE PLAN — What must I include in my surveillance plan?

Your surveillance plan must include a discussion of:

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

21 C.F.R. § 822.10