CDRH announced in May that two pathways for submitting electronic medical device reports (MDRs) are now available. The center believes that medical device adverse events are underreported and that an electronic system will help increase MDR frequency.
Small manufacturers that 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. The software can be accessed at www.fda.gov/cdrh/cesub.
Large manufacturers, which 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 e-mailing Indira Konduri, the eMDR project manager in the Office of Surveillance and Biometrics, at email@example.com.
In either case, OEMs that wish to submit electronic MDRs must register with the FDA Electronic Submissions Gateway. Information on doing so can be found at www.fda.gov/esg.
Those who need more information on the eMDR program can contact Konduri at 240/276-3459.