Increasing numbers of medical device makers will look offshore to introduce new medical technologies unless the FDA can make its 510(k) review process more predictable, according to researchers from Northwestern University.
The survey, sponsored by the non-profit Institute for Health Technology Studies, found that two-thirds of small medical device and diagnostic firms look to Europe for their first regulatory clearances. The researchers polled 356 experts in medical device development using an online survey. Nearly all of the respondents cited “the predictability of regulatory requirements is a crucial factor in deciding whether to invest in developing a new product,” according to a press release.
“Large and small companies reported that unclear guidelines, inconsistent implementation, and lead reviewer turnover are contributing to increasing unpredictability of the process,” according to the release. “Only 8 percent of survey respondents believe FDA’s 510(k) product review process is the most predictable regulatory system, as compared with roughly two-thirds of respondents who stated that Europe’s CE marking process is the most predictable.”
Uncertainty about the 510(k) process, by which the vast majority of medical devices are cleared for the U.S. market, was the leading factor in pushing new device introductions overseas, according to the survey. Three-quarters of those polled found that the preparation requirements for a 510(k) submission were “uncertain or unclear” and 72 percent said requests from FDA reviewers for more information fell outside the requirements detailed in the watchdog agency’s guidance documents. Nearly 60 percent reported that no guidance documents existed for their devices.
Turnover among the FDA’s cadre of reviewers was also a concern, with 14 percent reporting changes in the lead FDA reviewer for their submission. And the financial impact of FDA requests had “a significant impact” on financial resources for more than two-thirds of all respondents.
Other key findings include:
- Only 4 percent of respondents reported approaching FDA as the first regulator to discuss and plan their submission for a new device, while 80 percent initially approached EU regulatory bodies.
- 65 percent of devices were CE-marked before receiving FDA clearance.
- U.S. review time is more than twice as long as in the European Union (partly attributable to differences in regulatory requirements between the U.S. and the EU).
The 510(k) process has been under intense scrutiny since President Barack Obama appointed new administrators for the agency after taking office in 2009. The FDA conducted its own internal review of the process and is waiting on an independent report it commissioned from the Institute of Medicine, expected to drop later this summer.
Although it was founded and is funded by donations for “leaders of the medical technology industry,” according to its website, InHealth bills itself as “an independent, nonprofit organization to fund objective, peer-review quality research and analysis on the impact and value of medical devices and diagnostics” and claims not to represent the medical device or diagnostics industry or to advocate for or against particular med-tech products or government regulations.