Where can I find information on how to prepare and submit an MDR in electronic format?

  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. Generally Applicable Requirements for Individual Adverse Event Reports
  8. Where can I find information on how to prepare and submit an MDR in electronic format?

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§ 803.23 Where can I find information on how to prepare and submit an MDR in electronic format?

(a) You may obtain information on how to prepare and submit reports in an electronic format that FDA can process, review, and archive at: http://www.fda.gov/ForIndustry/FDAeSubmitter/ucm107903.htm.

(b) We may sometimes update information on how to prepare and submit reports electronically. If we do make modifications, we will ensure that we alert reporters by updating the eMDR Web page.


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