The US Food and Drug Administration is working to speed it reviews of medical devices and diagnostics, Commissioner Margaret Hamburg told attendees at the AdvaMed conference, as the Boston Globe reports.
For serious conditions for which there are currently no available products, FDA, Hamburg said, is looking into an expedited approval process for devices that could help in their treatment. Still, she noted that the agency has more fast-tracking options for experimental drugs.
Mark Deem, managing partner of the medical device startup incubator the Foundry, tells the Globe that it's too late as many entrepreneurs are taking their medical device startups abroad. Products are often approved as much as three years earlier in Europe than the US.
At the same time, Lisa McGiffert, manager of the Consumers Union Safe Patient Project, notes that FDA has to weigh both speed and safety.
“It's not really a race as to who's first,” Hamburg said. “It’s to get great products to individuals."