Code of Federal Regulations Title 21. Food and Drugs § 21.822.19 What kinds of decisions may you make?

(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