21 C.F.R. PART 822--POSTMARKET SURVEILLANCE
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 822--POSTMARKET SURVEILLANCE
Subpart A--GENERAL PROVISIONS
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| What does this part cover?
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| What is the purpose of this part?
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| How do you define the terms used in this part?
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| Does this part apply to me?
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Subpart B--NOTIFICATION
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| How will I know if I must conduct postmarket surveillance?
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| When will you notify me that I am required to conduct postmarket surveillance?
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| What should I do if I do not agree that postmarket surveillance is appropriate?
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Subpart C--POSTMARKET SURVEILLANCE PLAN
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| When, where, and how must I submit my postmarket surveillance plan?
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| What must I include in my submission?
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| What must I include in my surveillance plan?
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| What should I consider when designing my plan to conduct postmarket surveillance?
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| Do you have any information that will help me prepare my submission or design my postmarket surveillance plan?
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| May I reference information previously submitted instead of submitting it again?
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| How long must I conduct postmarket surveillance of my device?
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Subpart D--FDA REVIEW AND ACTION
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| What will you consider in the review of my submission?
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| How long will your review of my submission take?
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| How will I be notified of your decision?
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| What kinds of decisions may you make?
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| 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?
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| What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?
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| What recourse do I have if I do not agree with your decision?
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| Is the information in my submission considered confidential?
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Subpart E--RESPONSIBILITIES OF MANUFACTURERS
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| What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?
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| What are my responsibilities after my postmarket surveillance plan has been approved?
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| If my company changes ownership, what must I do?
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| If I go out of business, what must I do?
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| If I stop marketing the device subject to postmarket surveillance, what must I do?
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Subpart F--WAIVERS AND EXEMPTIONS
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| May I request a waiver of a specific requirement of this part?
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| May I request exemption from the requirement to conduct postmarket surveillance?
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Subpart G--RECORDS AND REPORTS
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| What records am I required to keep?
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| What records are the investigators in my surveillance plan required to keep?
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| How long must we keep the records?
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| What must I do with the records if the sponsor of the plan or an investigator in the plan changes?
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| Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?
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| Can you inspect and copy the records related to my postmarket surveillance plan?
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| Under what circumstances would you inspect records identifying subjects?
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| What reports must I submit to you?
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