FDA Review and Action | Midpage

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Code of Federal Regulations

Subpart D

FDA Review and Action

822.16What will you consider in the review of my submission?822.17How long will your review of my submission take?822.18How will I be notified of your decision?822.19What kinds of decisions may you make?822.20What 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?822.21What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?822.22What recourse do I have if I do not agree with your decision?822.23Is the information in my submission considered confidential?