21 CFR
Part 822 Postmarket Surveillance
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?
- § 822.14 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?