FDA 21 CFR Part 803 Medical Device Reporting:
Subpart A - General Provisions
803.1 What does this part cover?
803.3 How does FDA define the terms used in this part?
803.9 What information from the reports do we disclose to the public?
803.10 Generally, what are the reporting requirements that apply to me?
803.12 How do I submit initial and supplemental or followup reports?
803.13 Do I need to submit reports in English?
803.15 How will I know if you require more information about my medical device report?
Subpart B - Generally Applicable Requirements for Individual Adverse Event Reports
803.20 How do I complete and submit an individual adverse event report?
803.22 What are the circumstances in which I am not required to file a report?
803.23 Where can I find information on how to prepare and submit an MDR in electronic format?
Subpart C - User Facility Reporting Requirements
803.30 If I am a user facility, what reporting requirements apply to me?
803.33 If I am a user facility, what must I include when I submit an annual report?
Subpart D - Importer Reporting Requirements
803.40 If I am an importer, what reporting requirements apply to me?
803.42 If I am an importer, what information must I submit in my individual adverse event reports?
Subpart E - Manufacturer Reporting Requirements
803.50 If I am a manufacturer, what reporting requirements apply to me?
803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report?