(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