21 CFR Subpart A
General Provisions
June 25, 2020
§
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?
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