FDA 21 CFR Part 822 Postmarket Surveillance

FDA 21 CFR Part 822 Postmarket Surveillance

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Table of contents

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?

Subpart B - Notification

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?

822.12 Do you have any information that will help me prepare my submission or design my postmarket surveillance plan?

822.13 [Reserved]

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?

822.20 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?

Subpart E - Responsibilities of Manufacturers

822.24 What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?

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?

822.34 What must I do with the records if the sponsor of the plan or an investigator in the plan changes?

822.35 Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?

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?

822.38 What reports must I submit to you?

FDA 21 CFR Part 822 Postmarket Surveillance:

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