In a recent article from the Minneapolis Star Tribute, it was reported that getting a medical device cleared to market via the 510(k) is completely unpredictable and is a major source of concern to the industry. This has made Europe Preferred for Product Approval.

Two-thirds of small medical device and diagnostic companies (the drivers of innovation) in the sector are obtaining clearance for new products in Europe first, suggesting delayed market entry in the U.S.according to a comprehensive industry-wide survey about FDA's 510(k) product review process by researchers at Northwestern University.

Large and small companies reported that unclear guidelines, inconsistent implementation, and lead reviewer turnover are contributing to increasing unpredictability of the process. Only 8% 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.

U.S. regulatory system has been widely credited with ensuring high standards of patient safety and device effectiveness, while also facilitating innovation but increasing uncertainty about the implementation of the 510(k) process (partly attributable to increases in device complexity) is posing challenges for FDA and industry that may lead the United States to experience a "brain drain" in the medtech sector.

Through an online survey of more than 350 professionals engaged in medical device development, they found out the following results:

• Three-quarters of respondents (76%) found preparation requirements for a 510(k) submission to be uncertain or unclear; 72% felt that information requests from FDA reviewers went beyond the requirements established in guidance documents; and 59% reported no guidance documents existed for their devices.
• More than two-thirds of all respondents reported that FDA requests had a significant impact on their financial resources. small companies are more likely to incur expensive and time-consuming difficulties in navigating the process.
• The development process for small companies -- which are involved with new products twice as often as large companies -- is significantly longer than for large companies (26.6 months versus 17.7 months).
• Small company respondents report an average total review time of 330 days, while those in large companies report 177 days.
• Only 4% of respondents reported approaching FDA as the first regulator to discuss and plan their submission for a new device, while 80% initially approached EU regulatory bodies.
• In the device-specific portion of the survey, respondents said that 65% of devices were CE-marked before receiving FDA clearance.
• Data suggest that current U.S. review time is more than twice as long as in the EU (part of it attributable to differences in regulatory requirements between the U.S. and the EU).
• Respondents stated that their companies could have improved the initial submission for 39% of applications submitted in the past three years.
• On average, respondents felt that 26% of FDA's follow-up questions should have been anticipated.
• 92% of respondents perceived a correlation between inexperienced reviewers and more FDA questions.
• The survey findings are timely, as FDA's Center for Devices and Radiological Health (CDRH) is weighing regulatory revisions that support innovation; bring important, safe, and effective technologies to patients quickly; and keep jobs in the United States.

The last time this happened to this extent was in the early 1990s. Things have not got as bad as it was then but with all the new FDA personnel, the 510(k) paradigm the is trying to implement, it is causing havoc in the industry. As the FDA makes it harder and harder for new and improved medical devices get to market, the continues to allow older and outdated technology stay in the field. There has to be something done to corrected this situation.

Any questions on this survey please email us at info@mdiconsultants.com and Ref: Survey US regulatory .