The news came out in 2016 that medical device companies were late filing more than 300,000 adverse events reports to U.S. FDA.
“I think that’s simply embarrassing as an industry,” regulatory consultant Mike Drues said during his latest podcast with Medical Design & Outsourcing.
FDA’s solution has partly been to propose an easing of the reporting requirements. Medtech companies would be able to provide malfunction medical device reports (MDRs) in a summary format on a quarterly basis – instead of filing each individual MDR within 30 days.
Drues — a regulatory consultant based outside Boston who has worked with both medical device companies and FDA — doesn’t think the proposal will solve problems.
The proposal, for example, doesn’t include devices involved in a report of a death or serious injury, but that doesn’t always indicate the seriousness of the problem.
Some kind of triage system for MDRs might be better, according to Drues, who is president of Vascular Sciences. “It makes sense to report these problems sooner rather than later. … Companies have a responsibility once they put their product out on the market to keep an eye on it and identify problems.”
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