Home/CFR/Title 21/Part 803
FEDERAL · 21 CFR

Part 803 — Medical Device Reporting

26 sections · Title 21: Food and Drugs

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