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Is FDA's easing of medical device malfunctioning reporting a good thing?
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.
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By MedicalDesign&OutsourcingThe 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.