CFR /  Title 21  /  Part 822  /  Sec. 822.19 What kinds of decisions may you make?----------------------------------------------------------------------------------------------------------------

(a) Should result in the collection of An approval order, identifying Conduct postmarket surveillance

useful data that will address the any specific requirements of your device in accordance

postmarket surveillance question related to your postmarket with the approved plan

surveillance(b) Should result in the collection of An approvable letter identifying Revise your postmarket

useful data that will address the the specific revisions or surveillance submission to

postmarket surveillance question after information that must be address the concerns in the

specific revisions are made or specific submitted before your plan can approvable letter and submit it

information is provided be approved 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 A letter disapproving your plan Revise your postmarket

specified in this part and identifying the reasons for surveillance submission and

disapproval 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 A letter disapproving your plan Revise your postmarket

collection of useful data that will and identifying the reasons for surveillance submission and

address the postmarket surveillance disapproval submit it to us within the

question specified timeframe. We will

determine the timeframe case-by-

case, based on the types of

revisions or information that

you must submit----------------------------------------------------------------------------------------------------------------