| 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 |
