CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 822—POSTMARKET SURVEILLANCE > SUBPART D—FDA Review and Action (§822.16 to §822.23) > 822.19—What kinds of decisions may you make?

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