Title 21


Subpart A - General Provisions

21: 803.1
   803.1 What does this part cover
21: 803.3
   803.3 How does FDA define the terms used in this part
21: 803.9
   803.9 What information from the reports do we disclose to the public
21: 803.10
   803.10 Generally, what are the reporting requirements that apply to me
21: 803.11
   803.11 What form should I use to submit reports of individual adverse events and where do I obtain these forms
21: 803.12
   803.12 How do I submit initial and supplemental or followup reports
21: 803.13
   803.13 Do I need to submit reports in English
21: 803.15
   803.15 How will I know if you require more information about my medical device report
21: 803.16
   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
21: 803.17
   803.17 What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me
21: 803.18
   803.18 What are the requirements for establishing and maintaining MDR files or records that apply to me
21: 803.19
   803.19 Are there exemptions, variances, or alternative forms of adverse event reporting requirements