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e-CFR data is current as of March 5, 2021

Title 21Chapter ISubchapter HPart 803Subpart B → §803.23


Title 21: Food and Drugs
PART 803—MEDICAL DEVICE REPORTING
Subpart B—Generally Applicable Requirements for Individual Adverse Event Reports


§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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