Subpart A—General Provisions

1. CFR
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3. Title 21
4. ›
5. Chapter I
6. ›
7. Part 803
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9. Subpart A

Sections

Section numbering in the official eCFR can be non-consecutive. Omitted section numbers are not treated here as reserved unless the source explicitly labels them that way.

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