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 |