Subpart D. Subpart D—FDA Review and Action

• § 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?