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Title 21 - Title 21
Part 803 - MEDICAL DEVICE REPORTING
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Description
MEDICAL DEVICES - MEDICAL DEVICE REPORTING
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26 sections
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§803.1 - What does this part cover?
Title 21, Part 803
§803.10 - Generally, what are the reporting requirements that apply to me?
Title 21, Part 803
§803.11 - What form should I use to submit reports of individual adverse events and where do I obtain these forms?
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§803.12 - How do I submit initial and supplemental or followup reports?
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§803.13 - Do I need to submit reports in English?
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§803.15 - How will I know if you require more information about my medical device report?
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§803.16 - When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
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§803.17 - What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
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§803.18 - What are the requirements for establishing and maintaining MDR files or records that apply to me?
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§803.19 - Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
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§803.20 - How do I complete and submit an individual adverse event report?
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§803.21 - Where can I find the reporting codes for adverse events that I use with medical device reports?
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§803.22 - What are the circumstances in which I am not required to file a report?
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§803.23 - Where can I find information on how to prepare and submit an MDR in electronic format?
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§803.3 - How does FDA define the terms used in this part?
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§803.30 - If I am a user facility, what reporting requirements apply to me?
Title 21, Part 803
§803.32 - If I am a user facility, what information must I submit in my individual adverse event reports?
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§803.33 - If I am a user facility, what must I include when I submit an annual report?
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§803.40 - If I am an importer, what reporting requirements apply to me?
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§803.42 - If I am an importer, what information must I submit in my individual adverse event reports?
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§803.50 - If I am a manufacturer, what reporting requirements apply to me?
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§803.52 - If I am a manufacturer, what information must I submit in my individual adverse event reports?
Title 21, Part 803
§803.53 - If I am a manufacturer, in which circumstances must I submit a 5-day report?
Title 21, Part 803
§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?
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§803.58 - Foreign manufacturers.
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§803.9 - What information from the reports do we disclose to the public?
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