CFR /  Title 21  /  Part 822: Postmarket Surveillance

Section No.	Description
Section 822.1	What is the purpose of this part?
Section 822.2	How do you define the terms used in this part?
Section 822.3	Does this part apply to me?
Section 822.4	How will I know if I must conduct postmarket surveillance?
Section 822.5	When will you notify me that I am required to conduct postmarket surveillance?
Section 822.6	What should I do if I do not agree that postmarket surveillance is appropriate?
Section 822.7	When, where, and how must I submit my postmarket surveillance plan?
Section 822.8	What must I include in my submission?
Section 822.9	What must I include in my surveillance plan?
Section 822.10	What should I consider when designing my plan to conduct postmarket surveillance?
Section 822.11	Do you have any information that will help me prepare my submission or design my postmarket surveillance plan?
Section 822.12	May I reference information previously submitted instead of submitting it again?
Section 822.14	How long must I conduct postmarket surveillance of my device?
Section 822.15	What will you consider in the review of my submission?
Section 822.16	How long will your review of my submission take?
Section 822.17	How will I be notified of your decision?
Section 822.18	What kinds of decisions may you make?
Section 822.19	What are the consequences if I fail to submit a postmarket surveillance plan, my plan is disapproved and I fail to submit a new
Section 822.20	What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?
Section 822.21	What recourse do I have if I do not agree with your decision?
Section 822.22	Is the information in my submission considered confidential?
Section 822.23	What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?
Section 822.24	What are my responsibilities after my postmarket surveillance plan has been approved?
Section 822.25	If my company changes ownership, what must I do?
Section 822.26	If I go out of business, what must I do?
Section 822.27	If I stop marketing the device subject to postmarket surveillance, what must I do?
Section 822.28	May I request a waiver of a specific requirement of this part?
Section 822.29	May I request exemption from the requirement to conduct postmarket surveillance?
Section 822.30	What records am I required to keep?
Section 822.31	What records are the investigators in my surveillance plan required to keep?
Section 822.32	How long must we keep the records?
Section 822.33	What must I do with the records if the sponsor of the plan or an investigator in the plan changes?
Section 822.34	Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?
Section 822.35	Can you inspect and copy the records related to my postmarket surveillance plan?
Section 822.36	Under what circumstances would you inspect records identifying subjects?
Section 822.37	What reports must I submit to you?
Section 822.38	Definitions