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[A2]
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Electronic Code of Federal Regulations
| e-CFR data is current as of December 3, 2019
TITLE 21—Food and Drugs
CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) 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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| How do I submit initial and supplemental or followup reports? |
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| Do I need to submit reports in English? |
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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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| Where can I find information on how to prepare and submit an MDR in electronic format? |
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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 reporting requirements apply to me? |
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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 supplemental or followup report and what are the requirements for such reports? |
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