Adverse Events Reported to FDA via its MDR Program
The Silver Sheet
Adverse events reported to FDA via its MDR Program continue to skyrocket, leaving agency officials to hope that a soon-to-be-mandated switch to electronic Medical Device Reporting (eMDR) will ease its workload. According to statistics from CDRH’s Office of Surveillance and Biometrics, MDR reports spiked 144 percent between 2006 and 2007 – and the trend shows no signs of stopping. Currently only 12 manufacturers have joined the eMDR program, which has led FDA to reach out more aggressively to industry. “Each report that comes electronically is one less report we have to do data entry for,” says Indira Konduri, chief of OSB’s Information Analysis Branch.
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