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Regulations last checked for updates: May 14, 2025
Title 21 - Food and Drugs last revised: May 12, 2025
All Titles
Title 21
Chapter I
Part 803
Subpart A - 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?
authority:
21 U.S.C. 352
,
360
,
360
i,
360
j,
371
,
374
source:
79 FR 8846, Feb. 14, 2014, unless otherwise noted.
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