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Submit Medical Device Reports in eMDR Format to FDA

U.S. FDA CITATION: 21 C.F.R. § 803 (2016)
As a service to U.S. Agent clients, Registrar Corp will submit your company’s Medical Device Reports in eMDR format to FDA’s Electronic Gateway at no cost. Files must be created in FDA’s eSubmitter software. This software can be downloaded from the link below.

Download eSubmitter Software

Once you have created your Medical Device Report files in eSubmitter, upload the file and complete the required information below.

  • Accepted file types: jpg, jpeg, gif, png, pdf, doc, docx.

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