---
kind: "section"
citation: "21 C.F.R. § 822.10"
title: "21"
number: "822.10"
heading: "What must I include in my surveillance plan?"
url: "https://uscodex.org/cfr/21/822.10"
---

# §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.**

## Notes

### Authority

Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.

### Source

Source: 67 FR 38887, June 6, 2002, unless otherwise noted.