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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 803 - Medical Device Reporting |
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Subpart E - Manufacturer Reporting Requirements |
| § 803.50 - If I am a manufacturer, what reporting requirements apply to me? |
| § 803.52 - If I am a manufacturer, what information must I submit in my individual adverse event reports? |
| § 803.53 - If I am a manufacturer, in which circumstances must I submit a 5-day report? |
| § 803.55 - If I am a manufacturer, in what circumstances must I submit a baseline report, and what are the requirements for such a report? |
| § 803.56 - If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports? |
| § 803.57 - Annual certification. |
| § 803.58 - Foreign manufacturers. |