TITLE 21 - FOOD AND DRUGS

CHAPTER I - FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 822 - POSTMARKET SURVEILLANCE

subpart c - POSTMARKET SURVEILLANCE PLAN

822.10 - 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.