21 C.F.R. PART 803--MEDICAL DEVICE REPORTING
TITLE 21--Food and Drugs
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES
PART 803--MEDICAL DEVICE REPORTING
Subpart A--GENERAL PROVISIONS
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What does this part cover?
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How does FDA define the terms used in this part?
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What information from the reports do we disclose to the public?
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Generally, what are the reporting requirements that apply to me?
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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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Where and how do I submit reports and additional information?
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Do I need to submit reports in English?
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How do I submit a report electronically?
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How will I know if you require more information about my medical device report?
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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 reportable event?
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What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?
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What are the requirements for establishing and maintaining MDR files or records that apply to me?
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Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
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Subpart B--GENERALLY APPLICABLE REQUIREMENTS FOR INDIVIDUAL ADVERSE EVENT REPORTS
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How do I complete and submit an individual adverse event report?
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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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What are the circumstances in which I am not required to file a report?
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Subpart C--USER FACILITY REPORTING REQUIREMENTS
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If I am a user facility, what reporting requirements apply to me?
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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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If I am a user facility, what must I include when I submit an annual report?
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Subpart D--IMPORTER REPORTING REQUIREMENTS
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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 must I submit them?
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If I am an importer, what information must I submit in my individual adverse event reports?
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Subpart E--MANUFACTURER REPORTING REQUIREMENTS
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If I am a manufacturer, what reporting requirements apply to me?
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If I am a manufacturer, what information must I submit in my individual adverse event reports?
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If I am a manufacturer, in which circumstances must I submit a 5-day report?
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If I am a manufacturer, in what circumstances must I submit a baseline report, and what are the requirements for such a report?
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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 for such reports?
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