21 CFR § 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.
The following state regulations pages link to this page.