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Prepare for Electronic Medical Device Reporting (eMDR)

U.S. FDA CITATION 21 C.F.R. § 803.17

U.S. FDA requires medical device manufacturers and importers to develop written procedures that, among other requirements, account for timely submission of medical device reports in the case of an adverse event. Registrar Corp’s Regulatory Specialists can simplify this process by setting up your FDA Electronic Submissions Gateway (ESG) account and serving as your channel for prompt report submission.

For assistance with FDA eMDR requirements, simply complete the form below: