Roughly two-thirds of small medical device and diagnostic companies are obtaining clearance for new products in Europe first, delaying the availability of those products in the U.S., according to a study from Northwestern University reviewing the FDA's 510(k) process.
In a survey of 350 medical device professionals, researchers sought to determine what works well in the 510(k) process. They also aimed to provide insight into how U.S. companies are navigating the changing regulatory environment at home. They found that three-quarters of respondents found preparation requirements for a 510(k) submission to be uncertain or unclear; 72 percent answered that information requests from FDA reviewers went beyond the requirements established in guidance documents; and 59 percent reported no guidance documents existed for their devices.
In addition, only eight percent of responded said they believe the FDA's 510(k) product review process is the most predictable regulatory system, versus the roughly two-thirds of those who stated that Europe's CE marking process is the most predictable.
"The responses indicate that there may be opportunities for industry to better anticipate FDA's evidentiary needs during the regulatory process, as long as they are clearly stated and communicated," said lead researcher John Linehan in a statement. "Similarly, the process would benefit from FDA better training inexperienced reviewers on how to treat submissions consistently." He added that 92 percent of respondents perceived a correlation between inexperienced reviewers and more FDA questions.
CDRH head Jeffrey Shuren said at a news conference Tuesday that he appreciated the efforts by the researchers "on challenges we all face keeping the 510(k) process robust and maintaining the United States' edge in medical innovation while assuring patients receive devices that are safe and effective." But he added there were some limitations with the survey. He pointed out there are more than 5,000 device companies in the U.S., but only survey included responses from 350 individuals--with some questions getting even fewer responses, the Star Tribune reports.
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