Subpart D—FDA Review and Action

Sections

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