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e-CFR data is current as of March 4, 2021

Title 21Chapter ISubchapter HPart 822Subpart D → §822.19


Title 21: Food and Drugs
PART 822—POSTMARKET SURVEILLANCE
Subpart D—FDA Review and Action


§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 questionAn approval order, identifying any specific requirements related to your postmarket surveillanceConduct 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 providedAn approvable letter identifying the specific revisions or information that must be submitted before your plan can be approvedRevise 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 partA letter disapproving your plan and identifying the reasons for disapprovalRevise 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 questionA letter disapproving your plan and identifying the reasons for disapprovalRevise 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

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