FDA Review and Action

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Postmarket Surveillance
  7. FDA Review and Action

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Section
822.16

What will you consider in the review of my submission?

Section
822.17

How long will your review of my submission take?

Section
822.18

How will I be notified of your decision?

Section
822.19

What kinds of decisions may you make?

Section
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?

Section
822.21

What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?

Section
822.22

What recourse do I have if I do not agree with your decision?

Section
822.23

Is the information in my submission considered confidential?