21 C.F.R. § 803.23
Where can I find information on how to prepare and submit an MDR in electronic format?
Cite as 21 C.F.R. § 803.23 (2026)
(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
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(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.