21 CFR Part 822 — Postmarket Surveillance
Subpart A — General Provisions
Subpart B — Notification
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?
- § 822.20— 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
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?