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?
- § 803.11 What form should I use to submit reports of individual adverse events and where do I obtain these forms? 3 × 483
- § 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?
- § 803.16 When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
- § 803.17 What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me? 2,246 × 483
- § 803.18 What are the requirements for establishing and maintaining MDR files or records that apply to me? 64 × 483
- § 803.19 Are there exemptions, variances, or alternative forms of adverse event reporting requirements?
Subpart B - Generally Applicable Requirements for Individual Adverse Event Reports
- § 803.20 How do I complete and submit an individual adverse event report?
- § 803.21 Where can I find the reporting codes for adverse events that I use with medical device reports?
- § 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? 21 × 483
- § 803.32 If I am a user facility, what information must I submit in my individual adverse event reports? 1 × 483
- § 803.33 If I am a user facility, what must I include when I submit an annual report? 2 × 483
Subpart D - Importer Reporting Requirements
- § 803.40 If I am an importer, what reporting requirements apply to me? 31 × 483
- § 803.42 If I am an importer, what information must I submit in my individual adverse event reports? 1 × 483
Subpart E - Manufacturer Reporting Requirements
- § 803.50 If I am a manufacturer, what reporting requirements apply to me? 989 × 483
- § 803.52 If I am a manufacturer, what information must I submit in my individual adverse event reports? 58 × 483
- § 803.53 If I am a manufacturer, in which circumstances must I submit a 5-day report? 5 × 483
- § 803.56 If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports? 58 × 483
- § 803.58 Foreign manufacturers