Title 21

PART 822

Part 822 - Postmarket Surveillance

PART 822 - POSTMARKET SURVEILLANCE Authority:21 U.S.C. 331, 352, 360i, 360l, 371, 374. Source:67 FR 38887, June 6, 2002, unless otherwise noted.

21:8.0.1.1.14.1SUBPART A
Subpart A - General Provisions
21:8.0.1.1.14.1.1.1SECTION 822.1
   822.1 What does this part cover
21:8.0.1.1.14.1.1.2SECTION 822.2
   822.2 What is the purpose of this part
21:8.0.1.1.14.1.1.3SECTION 822.3
   822.3 How do you define the terms used in this part
21:8.0.1.1.14.1.1.4SECTION 822.4
   822.4 Does this part apply to me
21:8.0.1.1.14.2SUBPART B
Subpart B - Notification
21:8.0.1.1.14.2.1.1SECTION 822.5
   822.5 How will I know if I must conduct postmarket surveillance
21:8.0.1.1.14.2.1.2SECTION 822.6
   822.6 When will you notify me that I am required to conduct postmarket surveillance
21:8.0.1.1.14.2.1.3SECTION 822.7
   822.7 What should I do if I do not agree that postmarket surveillance is appropriate
21:8.0.1.1.14.3SUBPART C
Subpart C - Postmarket Surveillance Plan
21:8.0.1.1.14.3.1.1SECTION 822.8
   822.8 When, where, and how must I submit my postmarket surveillance plan
21:8.0.1.1.14.3.1.2SECTION 822.9
   822.9 What must I include in my submission
21:8.0.1.1.14.3.1.3SECTION 822.10
   822.10 What must I include in my surveillance plan
21:8.0.1.1.14.3.1.4SECTION 822.11
   822.11 What should I consider when designing my plan to conduct postmarket surveillance
21:8.0.1.1.14.3.1.5SECTION 822.12
   822.12 Do you have any information that will help me prepare my submission or design my postmarket surveillance plan
21:8.0.1.1.14.3.1.6SECTION 822.13
   822.13 [Reserved]
21:8.0.1.1.14.3.1.7SECTION 822.14
   822.14 May I reference information previously submitted instead of submitting it again
21:8.0.1.1.14.3.1.8SECTION 822.15
   822.15 How long must I conduct postmarket surveillance of my device
21:8.0.1.1.14.4SUBPART D
Subpart D - FDA Review and Action
21:8.0.1.1.14.4.1.1SECTION 822.16
   822.16 What will you consider in the review of my submission
21:8.0.1.1.14.4.1.2SECTION 822.17
   822.17 How long will your review of my submission take
21:8.0.1.1.14.4.1.3SECTION 822.18
   822.18 How will I be notified of your decision
21:8.0.1.1.14.4.1.4SECTION 822.19
   822.19 What kinds of decisions may you make
21:8.0.1.1.14.4.1.5SECTION 822.20
   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
21:8.0.1.1.14.4.1.6SECTION 822.21
   822.21 What must I do if I want to make changes to my postmarket surveillance plan after you have approved it
21:8.0.1.1.14.4.1.7SECTION 822.22
   822.22 What recourse do I have if I do not agree with your decision
21:8.0.1.1.14.4.1.8SECTION 822.23
   822.23 Is the information in my submission considered confidential
21:8.0.1.1.14.5SUBPART E
Subpart E - Responsibilities of Manufacturers
21:8.0.1.1.14.5.1.1SECTION 822.24
   822.24 What are my responsibilities once I am notified that I am required to conduct postmarket surveillance
21:8.0.1.1.14.5.1.2SECTION 822.25
   822.25 What are my responsibilities after my postmarket surveillance plan has been approved
21:8.0.1.1.14.5.1.3SECTION 822.26
   822.26 If my company changes ownership, what must I do
21:8.0.1.1.14.5.1.4SECTION 822.27
   822.27 If I go out of business, what must I do
21:8.0.1.1.14.5.1.5SECTION 822.28
   822.28 If I stop marketing the device subject to postmarket surveillance, what must I do
21:8.0.1.1.14.6SUBPART F
Subpart F - Waivers and Exemptions
21:8.0.1.1.14.6.1.1SECTION 822.29
   822.29 May I request a waiver of a specific requirement of this part
21:8.0.1.1.14.6.1.2SECTION 822.30
   822.30 May I request exemption from the requirement to conduct postmarket surveillance
21:8.0.1.1.14.7SUBPART G
Subpart G - Records and Reports
21:8.0.1.1.14.7.1.1SECTION 822.31
   822.31 What records am I required to keep
21:8.0.1.1.14.7.1.2SECTION 822.32
   822.32 What records are the investigators in my surveillance plan required to keep
21:8.0.1.1.14.7.1.3SECTION 822.33
   822.33 How long must we keep the records
21:8.0.1.1.14.7.1.4SECTION 822.34
   822.34 What must I do with the records if the sponsor of the plan or an investigator in the plan changes
21:8.0.1.1.14.7.1.5SECTION 822.35
   822.35 Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan
21:8.0.1.1.14.7.1.6SECTION 822.36
   822.36 Can you inspect and copy the records related to my postmarket surveillance plan
21:8.0.1.1.14.7.1.7SECTION 822.37
   822.37 Under what circumstances would you inspect records identifying subjects
21:8.0.1.1.14.7.1.8SECTION 822.38
   822.38 What reports must I submit to you