Code of Federal Regulations (Last Updated: May 6, 2024) |
Title 21 - Food and Drugs |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
SubChapter H - Medical Devices |
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? |
§ 803.14 - 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? |