21 CFR § 822.19
What kinds of decisions may you make?
June 25, 2020
Open Table
| 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 |
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