[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR822.19]

[Page 161]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 822--POSTMARKET SURVEILLANCE--Table of Contents
 
                    Subpart D--FDA Review and Action
 
Sec. 822.19  What kinds of decisions may you make?

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               If your plan:                      Then we will send you:                 And you must:
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(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
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