Title 21


Subpart D - FDA Review and Action

21: 822.16
   822.16 What will you consider in the review of my submission
21: 822.17
   822.17 How long will your review of my submission take
21: 822.18
   822.18 How will I be notified of your decision
21: 822.19
   822.19 What kinds of decisions may you make
21: 822.20
   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
21: 822.21
   822.21 What must I do if I want to make changes to my postmarket surveillance plan after you have approved it
21: 822.22
   822.22 What recourse do I have if I do not agree with your decision
21: 822.23
   822.23 Is the information in my submission considered confidential