Small medical device companies shorted by FDA 510(k) review, study says

Here’s another report of how medical device and diagnostic companies are favoring the European regulatory regime over the one created by the U.S. Food and Drug Administration – especially when it comes to the510(k) review.

Northwestern University researchers did an online survey of 350 medical technology professionals between December and February. They found two-thirds of small American med tech firms are getting European market approval first compared with only 4 percent who report going the domestic route first and getting FDA approval.

Only 8 percent of survey respondents believe the 510(k) product review process is the most predictable regulatory system. Meanwhile, two-thirds of respondents said that Europe’s CE marking process is the most predictable when seeking approval for new innovative medical devices. A full 98 percent of respondents said the predictability of regulatory requirements is the crucial factor in deciding whether to invest in developing a new product.

The survey results released Tuesday are part of a larger study entitled “A Comprehensive Analysis of the 510(k) Process: Industry Practice and the Implications for Reform” and is funded by the nonprofit Institute for Health Technology Studies. Over the next few months Northwestern University researchers plan to expand on these survey findings through qualitative data and a more in-depth review of the American and European regulatory processes.

“As FDA considers regulatory revisions, what’s at stake is the ability of companies to attract investors in order to continue to develop innovative, life-saving products and sustain American competitiveness in the global marketplace,” said John Linehan, professor of biomedical engineering at Northwestern University and the lead researcher of the study, in a news release.

Other key findings of the survey are:

• In the last three years, respondents saw turnover in the lead FDA reviewer for about 14 percent of their submissions. Of those who experienced a lead reviewer change, 60 percent said it negatively affected the product review process
• 76 percent of respondents found preparation requirements for a 510(k) submission to be uncertain or unclear, while 72 percent felt that information requests from FDA reviewers went beyond the requirements established in guidance documents
• Respondents from small companies reported an average total review time of 330 days, compared to 177 days for larger companies
• 75 percent of respondents felt that the FDA began requesting more information during the 75-90 day period of a 510(k) submission although 510(k)s are supposed to be awarded within 90 days.

Despite the report focusing on the concerns of those involved in the 510(k) review process, it identified certain things that companies could be doing better, too.

• Survey respondents said that their companies could have improved the initial submission for 39 percent of applications submitted to the agency in the past three years.
• On average, the respondents said that 26 percent of FDA’s follow up questions shouldhave been anticipated.

“The responses indicate that there may be opportunities for the industry to better anticipate FDA’s evidentiary needs during the regulatory process, as long as they are clearly stated and communicated,” said Jan Pietzsch, president and EO of Wing Tech Consulting, and a co-investigator of the study, in a news release.