October 10, 2011
CHICAGO (Oct. 10, 1:25 p.m. ET) — The time-consuming process and high cost of getting medical devices approved in the United States is prompting the majority of medical device and diagnostic companies to launch their products overseas first.
An online survey of 350 medical device companies funded by the medical technology industry’s Institute for Health Technology Studies found that more than 75 percent of device manufacturers seek regulatory approval overseas first for new medical devices.
The study was conducted for InHealth by Northwestern University.
Almost two-thirds of the companies surveyed, 63 percent, said they sought approval overseas first because of the unpredictably of the 501 (k) review and approval process of the Food & Drug Administration.
Another 22 percent said the high costs of FDA review sent them overseas, and 14 percent said they first sought approval overseas for new medical devices because of the lengthy and complicated U.S. review process, which they said was twice as long as in the European Union.
Small companies surveyed said they experienced an average total review time by the FDA of 330 days compared to the average review time by the FDA of 177 days reported by large companies.
The online survey also found that the medical device development process for small companies—which are involved with new products twice as often as large companies—is 50 percent longer than for large companies, 26. 6 months versus 17.7 months.
More than three-quarters of respondents—76 percent—said they found the preparation requirements for a 510(k) submission to be uncertain or unclear, and 72 percent said they felt that the information requests from FDA reviewers went beyond the requirements established in guidance documents.
Not surprisingly, only eight percent of survey respondents said that they viewed the FDA’s 510(k) product review process as the most predictable regulatory system. Some two-thirds of respondents said that Europe’s CE marking process is the most predictable regulatory system for medical device approval.