21 CFR § 822.19 - What kinds of decisions may you make?
---
identifier: "/us/cfr/t21/s822.19"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 822.19 - What kinds of decisions may you make?"
title_number: 21
title_name: "Food and Drugs"
section_number: "822.19"
section_name: "What kinds of decisions may you make?"
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"
---
# 822.19 What kinds of decisions may you make?
| If your plan: | Then we will send you: | And you must: |
| --- | --- | --- |
| (a) Should result in the collection of useful data that will address the postmarket surveillance question | An approval order, identifying any specific requirements related to your postmarket surveillance | Conduct postmarket surveillance of your device in accordance with the approved plan |
| (b) Should result in the collection of useful data that will address the postmarket surveillance question after specific revisions are made or specific information is provided | An approvable letter identifying the specific revisions or information that must be submitted before your plan can be approved | Revise your postmarket surveillance submission to address the concerns in the approvable letter and submit it to us within the specified timeframe. We will determine the timeframe case-by-case, based on the types of revisions or information that you must submit |
| (c) Does not meet the requirements specified in this part | A letter disapproving your plan and identifying the reasons for disapproval | Revise your postmarket surveillance submission and submit it to us within the specified timeframe. We will determine the timeframe case-by-case, based on the types of revisions or information that you must submit |
| (d) Is not likely to result in the collection of useful data that will address the postmarket surveillance question | A letter disapproving your plan and identifying the reasons for disapproval | Revise your postmarket surveillance submission and submit it to us within the specified timeframe. We will determine the timeframe case-by-case, based on the types of revisions or information that you must submit |