{"data":{"id":"us/21-cfr-822.10","jurisdiction":"us","citation":"21 CFR 822.10","heading":"What must I include in my surveillance plan?","body":"Your surveillance plan must include a discussion of:\n(a) The plan objective(s) addressing the surveillance question(s) identified in our order;\n(b) The subject of the study, e.g., patients, the device, animals;\n(c) The variables and endpoints that will be used to answer the surveillance question, e.g., clinical parameters or outcomes;\n(d) The surveillance approach or methodology to be used;\n(e) Sample size and units of observation;\n(f) The investigator agreement, if applicable;\n(g) Sources of data, e.g., hospital records;\n(h) The data collection plan and forms;\n(i) The consent document, if applicable;\n(j) Institutional Review Board information, if applicable;\n(k) The patient followup plan, if applicable;\n(l) The procedures for monitoring conduct and progress of the surveillance;\n(m) An estimate of the duration of surveillance;\n(n) All data analyses and statistical tests planned;\n(o) The content and timing of reports.","path":["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"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"5e631dc9174ac87363411f751879259e1e9f2141cd6e8746b5297b6119c0b2bd","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-822.9","next":"us/21-cfr-822.11"},"notice":"GroundRules: Original legal text. Not legal advice."}