21 CFR 822.19 - What kinds of decisions may you make?

Regulations last checked for updates: Nov 22, 2024

Title 21 - Food and Drugs last revised: Nov 19, 2024

View all text of Subpart D [§ 822.16 - § 822.23]

§ 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 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

authority: 21 U.S.C. 331,352,360i,360l,371,374

source: 67 FR 38887, June 6, 2002, unless otherwise noted.

cite as: 21 CFR 822.19

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