21 CFR § 822.11 - What should I consider when designing my plan to conduct postmarket surveillance?

---
identifier: "/us/cfr/t21/s822.11"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 822.11 - What should I consider when designing my plan to conduct postmarket surveillance?"
title_number: 21
title_name: "Food and Drugs"
section_number: "822.11"
section_name: "What should I consider when designing my plan to conduct postmarket surveillance?"
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"
---


# 822.11 What should I consider when designing my plan to conduct postmarket surveillance?

You must design your surveillance to address the postmarket surveillance question identified in the order you received. You should consider what, if any, patient protection measures should be incorporated into your plan. You should also consider the function, operating characteristics, and intended use of your device when designing a surveillance approach.