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Title 21 - Title 21
Part 822 - POSTMARKET SURVEILLANCE
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Details about Part 822
Description
MEDICAL DEVICES - POSTMARKET SURVEILLANCE
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38 sections
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§822.1 - What does this part cover?
Title 21, Part 822
§822.10 - What must I include in my surveillance plan?
Title 21, Part 822
§822.11 - What should I consider when designing my plan to conduct postmarket surveillance?
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§822.12 - Do you have any information that will help me prepare my submission or design my postmarket surveillance plan?
Title 21, Part 822
§822.13 - Unknown
Title 21, Part 822
§822.14 - May I reference information previously submitted instead of submitting it again?
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§822.15 - How long must I conduct postmarket surveillance of my device?
Title 21, Part 822
§822.16 - What will you consider in the review of my submission?
Title 21, Part 822
§822.17 - How long will your review of my submission take?
Title 21, Part 822
§822.18 - How will I be notified of your decision?
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§822.19 - What kinds of decisions may you make?
Title 21, Part 822
§822.2 - What is the purpose of this part?
Title 21, Part 822
§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?
Title 21, Part 822
§822.21 - What must I do if I want to make changes to my postmarket surveillance plan after you have approved it?
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§822.22 - What recourse do I have if I do not agree with your decision?
Title 21, Part 822
§822.23 - Is the information in my submission considered confidential?
Title 21, Part 822
§822.24 - What are my responsibilities once I am notified that I am required to conduct postmarket surveillance?
Title 21, Part 822
§822.25 - What are my responsibilities after my postmarket surveillance plan has been approved?
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§822.26 - If my company changes ownership, what must I do?
Title 21, Part 822
§822.27 - If I go out of business, what must I do?
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§822.28 - If I stop marketing the device subject to postmarket surveillance, what must I do?
Title 21, Part 822
§822.29 - May I request a waiver of a specific requirement of this part?
Title 21, Part 822
§822.3 - How do you define the terms used in this part?
Title 21, Part 822
§822.30 - May I request exemption from the requirement to conduct postmarket surveillance?
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§822.31 - What records am I required to keep?
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§822.32 - What records are the investigators in my surveillance plan required to keep?
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§822.33 - How long must we keep the records?
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§822.34 - What must I do with the records if the sponsor of the plan or an investigator in the plan changes?
Title 21, Part 822
§822.35 - Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?
Title 21, Part 822
§822.36 - Can you inspect and copy the records related to my postmarket surveillance plan?
Title 21, Part 822
§822.37 - Under what circumstances would you inspect records identifying subjects?
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§822.38 - What reports must I submit to you?
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§822.4 - Does this part apply to me?
Title 21, Part 822
§822.5 - How will I know if I must conduct postmarket surveillance?
Title 21, Part 822
§822.6 - When will you notify me that I am required to conduct postmarket surveillance?
Title 21, Part 822
§822.7 - What should I do if I do not agree that postmarket surveillance is appropriate?
Title 21, Part 822
§822.8 - When, where, and how must I submit my postmarket surveillance plan?
Title 21, Part 822
§822.9 - What must I include in my submission?
Title 21, Part 822