SUBPART A—General Provisions (§803.1 to §803.19)
- 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—Where and how do I submit reports and additional information?
- 803.13—Do I need to submit reports in English?
- 803.14—How do I submit a report electronically?
- 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?