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Section 803.1
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How does FDA define the terms used in this part? |
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Section 803.3
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What information from the reports do we disclose to the public? |
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Section 803.9
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Generally, what are the reporting requirements that apply to me? |
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Section 803.10
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What form should I use to submit reports of individual adverse events and where do I obtain these forms? |
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Section 803.11
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Where and how do I submit reports and additional information? |
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Section 803.12
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Do I need to submit reports in English? |
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Section 803.13
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How do I submit a report electronically? |
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Section 803.14
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How will I know if you require more information about my medical device report? |
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Section 803.15
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When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the |
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Section 803.16
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What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me? |
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Section 803.17
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What are the requirements for establishing and maintaining MDR files or records that apply to me? |
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Section 803.18
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Are there exemptions, variances, or alternative forms of adverse event reporting requirements? |
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Section 803.19
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How do I complete and submit an individual adverse event report? |
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Section 803.20
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Where can I find the reporting codes for adverse events that I use with medical device reports? |
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Section 803.21
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What are the circumstances in which I am not required to file a report? |
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Section 803.22
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If I am a user facility, what reporting requirements apply to me? |
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Section 803.30
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If I am a user facility, what information must I submit in my individual adverse event reports? |
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Section 803.32
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If I am a user facility, what must I include when I submit an annual report? |
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Section 803.33
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If I am an importer, what kinds of individual adverse event reports must I submit, when must I submit them, and to whom |
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Section 803.40
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If I am an importer, what information must I submit in my individual adverse event reports? |
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Section 803.42
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If I am a manufacturer, what reporting requirements apply to me? |
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Section 803.50
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If I am a manufacturer, what information must I submit in my individual adverse event reports? |
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Section 803.52
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If I am a manufacturer, in which circumstances must I submit a 5-day report? |
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Section 803.53
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If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements |
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Section 803.56
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Foreign manufacturers |
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Section 803.58
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What does this part cover? |
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Section 803.1
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How does FDA define the terms used in this part? |
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Section 803.3
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What information from the reports do we disclose to the public? |
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Section 803.9
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Generally, what are the reporting requirements that apply to me? |
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Section 803.10
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What form should I use to submit reports of individual adverse events and where do I obtain these forms? |
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Section 803.11
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How do I submit initial and supplemental or followup reports? |
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Section 803.12
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Do I need to submit reports in English? |
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Section 803.13
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How will I know if you require more information about my medical device report? |
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Section 803.15
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When I submit a report, does the information in my report constitute an admission that the device caused or contributed |
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Section 803.16
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What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me? |
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Section 803.17
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What are the requirements for establishing and maintaining MDR files or records that apply to me? |
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Section 803.18
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Are there exemptions, variances, or alternative forms of adverse event reporting requirements? |
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Section 803.19
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How do I complete and submit an individual adverse event report? |
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Section 803.20
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Where can I find the reporting codes for adverse events that I use with medical device reports? |
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Section 803.21
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What are the circumstances in which I am not required to file a report? |
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Section 803.22
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Where can I find information on how to prepare and submit an MDR in electronic format? |
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Section 803.23
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If I am a user facility, what reporting requirements apply to me? |
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Section 803.30
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If I am a user facility, what information must I submit in my individual adverse event reports? |
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Section 803.32
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If I am a user facility, what must I include when I submit an annual report? |
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Section 803.33
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If I am an importer, what reporting requirements apply to me? |
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Section 803.40
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If I am an importer, what information must I submit in my individual adverse event reports? |
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Section 803.42
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If I am a manufacturer, what reporting requirements apply to me? |
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Section 803.50
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If I am a manufacturer, what information must I submit in my individual adverse event reports? |
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Section 803.52
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If I am a manufacturer, in which circumstances must I submit a 5-day report? |
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Section 803.53
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If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the |
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Section 803.56
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Foreign manufacturers |
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Section 803.58
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Scope |