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

---
identifier: "/us/cfr/t21/s822.10"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 822.10 - What must I include in my surveillance plan?"
title_number: 21
title_name: "Food and Drugs"
section_number: "822.10"
section_name: "What must I include in my surveillance plan?"
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "822"
part_name: "POSTMARKET SURVEILLANCE"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 331, 352, 360i, 360l, 371, 374."
regulatory_source: "67 FR 38887, June 6, 2002, unless otherwise noted."
cfr_part: "822"
---


# 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.