The unpredictability of the US Food and Drug Administration’s (FDA’s) 510(k) clearance process for medical devices is increasingly leading device makers, particularly smaller ones, to pursue approvals in Europe first, says a new report. The study conducted by researchers from Northwestern University and funded by the nonprofit Institute for Health Technology Studies (InHealth), surveyed more than 350 professionals engaged in medical device development. Speaking at the press conference announcing the study results, Dr. Jeffrey Shuren, head of the FDA's Center for Devices and Radiological Health, said that it “validates actions we are already taking” to improve the 510(k) system, but also pointed to “limitations” of the study, in that the survey’s 350 respondents represent less than 10% of the device industry.
Study calls FDA a drag on innovation (Star Tribune, Minneapolis)
Shuren: Northwestern survey "validates actions we are already taking" (Mass Device)
Small device firms file in EU first (PM Live)
Northwestern Survey Finds FDA Predictability a Top Concern Among Medtech Firms; Europe Preferred for Product Approval (InHealth press release)