Subpart A - General Provisions
822.1 What does this part cover?
822.2 What is the purpose of this part?
822.3 How do you define the terms used in this part?
822.4 Does this part apply to me?
822.5 How will I know if I must conduct postmarket surveillance?
822.6 When will you notify me that I am required to conduct postmarket surveillance?
822.7 What should I do if I do not agree that postmarket surveillance is appropriate?
Subpart C - Postmarket Surveillance Plan
822.8 When, where, and how must I submit my postmarket surveillance plan?
822.9 What must I include in my submission?
822.10 What must I include in my surveillance plan?
822.11 What should I consider when designing my plan to conduct postmarket surveillance?
822.14 May I reference information previously submitted instead of submitting it again?
822.15 How long must I conduct postmarket surveillance of my device?
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?
822.22 What recourse do I have if I do not agree with your decision?
822.23 Is the information in my submission considered confidential?
Subpart E - Responsibilities of Manufacturers
822.25 What are my responsibilities after my postmarket surveillance plan has been approved?
822.26 If my company changes ownership, what must I do?
822.27 If I go out of business, what must I do?
822.28 If I stop marketing the device subject to postmarket surveillance, what must I do?
Subpart F - Waivers and Exemptions
822.29 May I request a waiver of a specific requirement of this part?
822.30 May I request exemption from the requirement to conduct postmarket surveillance?
Subpart G - Records and Reports
822.31 What records am I required to keep?
822.32 What records are the investigators in my surveillance plan required to keep?
822.33 How long must we keep the records?
822.36 Can you inspect and copy the records related to my postmarket surveillance plan?
822.37 Under what circumstances would you inspect records identifying subjects?