21 CFR § 822.6 - When will you notify me that I am required to conduct postmarket surveillance?

---
identifier: "/us/cfr/t21/s822.6"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 822.6 - When will you notify me that I am required to conduct postmarket surveillance?"
title_number: 21
title_name: "Food and Drugs"
section_number: "822.6"
section_name: "When will you notify me that I am required 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"
---


# 822.6 When will you notify me that I am required to conduct postmarket surveillance?

We will notify you as soon as we have determined that postmarket surveillance of your device is necessary, based on the identification of a surveillance question. This may occur during the review of a marketing application for your device, as your device goes to market, or after your device has been marketed for a period of time.