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?
- § 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?
- § 803.18— What are the requirements for establishing and maintaining MDR files or records that apply to me?
- § 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
Subpart D — Importer Reporting Requirements
Subpart E — Manufacturer Reporting Requirements
- § 803.50— If I am a manufacturer, what reporting requirements apply to me?
- § 803.52— If I am a manufacturer, what information must I submit in my individual adverse event reports?
- § 803.53— If I am a manufacturer, in which circumstances must I submit a 5-day report?
- § 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?
- § 803.58— Foreign manufacturers.