High costs, long review times and increasing unpredictability led more than three-quarters of medical device makers to seek overseas regulatory approval before launching a bid for FDA clearance, according to the largest-ever survey on the 510(k) review process.
Of 350 medical device company employees reviewed, 22 percent said high costs of FDA review sent them overseas and 14 percent blamed a lengthy and complicated U.S. review process, according to a report by researchers at Northwestern University.
Nearly all of the remaining 63 percent of respondents cited unpredictability as the main reason for going abroad before applying for FDA clearance, the researchers reported.
The study, which was paid for by the Institute for Health Technology Studies, drew responses from employees of small, medium and large med-tech companies recently involved in 510(k) submissions. The institute is a non-profit funded by the medical device industry.
The findings and analysis were sent to the FDA as a counter to the Institute of Medicine’s controversial report, released this summer. The IOM recommended that the federal watchdog agency scrap the 510(k) program altogether and start from scratch with an "integrated pre-market and post-market regulatory framework."
The 22-month, independent IOM review, commissioned in 2009 by the FDA’s Center for Devices & Radiological Health, wasn’t binding on the agency but caused a stir in med-tech circles and draw the attention of members of Congress.
The report was met with support from the the New England Journal of Medicine, which wrote that the 510(k) process was outdated.
"As devices have evolved and become more complex, our device-approval system has become incapable of assuring safety and effectiveness," wrote NEJM executive editor Dr. Gregory Curfman and Dr. Rita Redberg, editor of the Archives of Internal Medicine. "The system we use today was created 35 years ago in an era of much simpler and fewer devices, and it is now outdated."
The IOM recommendations also drew the ire of med-tech industry representatives, who viewed the report as a non-started.
"Industry indicated that the IOM’s recommendations were so far outside the scope that the report does not provide meaningful answers to the questions FDA asked," industry reps told the FDA during negotiations over re-authorizing the Medical Device User Fee & Modernization Act. "Industry also expressed concern with the IOM’s statement that the 510(k) program is not designed to address safety and effectiveness, and encouraged FDA to rebut this contention."