General Provisions

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Medical Device Reporting
  7. General Provisions

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Section
803.1

What does this part cover?

Section
803.3

How does FDA define the terms used in this part?

Section
803.9

What information from the reports do we disclose to the public?

Section
803.10

Generally, what are the reporting requirements that apply to me?

Section
803.11

What form should I use to submit reports of individual adverse events and where do I obtain these forms?

Section
803.12

How do I submit initial and supplemental or followup reports?

Section
803.13

Do I need to submit reports in English?

Section
803.15

How will I know if you require more information about my medical device report?

Section
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?

Section
803.17

What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?

Section
803.18

What are the requirements for establishing and maintaining MDR files or records that apply to me?

Section
803.19

Are there exemptions, variances, or alternative forms of adverse event reporting requirements?