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FDA's Proposed eMDR Rule Aims To Improve Post-Market Surveillance

This article was originally published in The Silver Sheet

Executive Summary

A PROPOSED RULE MANDATING ELECTRONIC MEDICAL DEVICE REPORTING will help FDA spot post-market device problems more quickly, agency officials say. Although electronic adverse event reporting has been available since 2006, voluntary participation by manufacturers has been low, says Howard Press, who helped author the proposed regulation. Firms need "to see the handwriting on the wall," he says. "The program is going to become mandatory, so it will be easier [for companies] to implement it now rather than later." Manufacturers will have one year to comply with the eMDR rule once it becomes law, and FDA is predicting that the program will save the agency and manufacturers money. Meanwhile, the total number of adverse events reported to FDA under the MDR program decreased in 2008. Also in this issue, Jonathan Sackner-Bernstein, associate director of CDRH's post-market operations, provides an update on the agency's post-market initiative and matrix team
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