21 C.F.R. § 822.19 What kinds of decisions may you make?
Title 21 - Food and Drugs
Title 21: Food and Drugs
PART 822—POSTMARKET SURVEILLANCE
Subpart D—FDA Review and Action
§ 822.19 What kinds of decisions may you make?
---------------------------------------------------------------------------------------------------------------- If your plan: Then we will send you: And you must:----------------------------------------------------------------------------------------------------------------(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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