Home/CFR/Title 21/Part 822
FEDERAL · 21 CFR

Part 822 — Postmarket Surveillance

38 sections · Title 21: Food and Drugs

§ 822.1What does this part cover?
§ 822.2What is the purpose of this part?
§ 822.3How do you define the terms used in this part?
§ 822.4Does this part apply to me?
§ 822.5How will I know if I must conduct postmarket surveillance?
§ 822.6When will you notify me that I am required to conduct postmarket surveillance?
§ 822.7What should I do if I do not agree that postmarket surveillance is appropriate?
§ 822.8When, where, and how must I submit my postmarket surveillance plan?
§ 822.9What must I include in my submission?
§ 822.10What must I include in my surveillance plan?
§ 822.11What should I consider when designing my plan to conduct postmarket surveillance?
§ 822.12Do you have any information that will help me prepare my submission or design my postmarket surveillance plan?
§ 822.13§ 822.13 [Reserved]
§ 822.14May I reference information previously submitted instead of submitting it again?
§ 822.15How long must I conduct postmarket surveillance of my device?
§ 822.16What will you consider in the review of my submission?
§ 822.17How long will your review of my submission take?
§ 822.18How will I be notified of your decision?
§ 822.19What kinds of decisions may you make?
§ 822.20What 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?
§ 822.21What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?
§ 822.22What recourse do I have if I do not agree with your decision?
§ 822.23Is the information in my submission considered confidential?
§ 822.24What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?
§ 822.25What are my responsibilities after my postmarket surveillance plan has been approved?
§ 822.26If my company changes ownership, what must I do?
§ 822.27If I go out of business, what must I do?
§ 822.28If I stop marketing the device subject to postmarket surveillance, what must I do?
§ 822.29May I request a waiver of a specific requirement of this part?
§ 822.30May I request exemption from the requirement to conduct postmarket surveillance?
§ 822.31What records am I required to keep?
§ 822.32What records are the investigators in my surveillance plan required to keep?
§ 822.33How long must we keep the records?
§ 822.34What must I do with the records if the sponsor of the plan or an investigator in the plan changes?
§ 822.35Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?
§ 822.36Can you inspect and copy the records related to my postmarket surveillance plan?
§ 822.37Under what circumstances would you inspect records identifying subjects?
§ 822.38What reports must I submit to you?