21 CFR Subpart D
FDA Review and Action
June 25, 2020
§
822.16
What will you consider in the review of my submission?
§
822.17
How long will your review of my submission take?
§
822.18
How will I be notified of your decision?
§
822.19
What kinds of decisions may you make?
§
822.20
What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new plan, or I fail to conduct surveillance in accordance with my approved plan?
§
822.21
What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?
§
822.22
What recourse do I have if I do not agree with your decision?
§
822.23
Is the information in my submission considered confidential?
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