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Code of Federal Regulations (Last Updated: April 5, 2024) |
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Title 21 - Food and Drugs |
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Chapter I - Food and Drug Administration, Department of Health and Human Services |
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SubChapter H - Medical Devices |
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Part 822 - Postmarket 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? |
| § 822.21 - 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? |