Electronic MDRs Now a Reality

CDRH has unveiled two pathways to facilitate electronic Medical Device Reporting. This will hopefully increase the volume of MDRs, which are underreported.Small manufacturers who don't anticipate making many MDRs can use a program called CDRH eSubmitter, or CeSub. To use it, they can download special software, which runs on a PC and allows users to submit one report at a time.Large manufacturers, who may need to submit hundreds of reports per year, can use a batch submission protocol in accordance with the health informatics standard known as HL7. An information guide on HL7 can be obtained by emailing [email protected].In either case, the manufacturer must register with the FDA Electronic Submissions Gateway.