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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
 
PART 822POSTMARKET 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?
   § 822.13 - [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?

Authority: 21 U.S.C. 331, 352, 360i, 360l, 371, 374.
Source: 67 FR 38887, June 6, 2002, unless otherwise noted.

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