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Code of Federal Regulations (Last Updated: November 8, 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 |
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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? |