The FDA has made important strides in improving its medical device review process, devices chief Dr. Jeffrey Shuren said this week.
Since beginning an audit of the agency’s med-tech review procedures nearly 2 years ago, fewer medical device market applications have been sent back to companies and average decision times are on the decline, Shuren told an audience at the Memphis Bioworks Assn. Monday.
The head of the FDA’s Center for Devices & Radiological Health detailed the watchdog agency’s plan for more transparent and predictable medical device review, explaining how the latest iteration of a user fee agreement will further those goals.
The Medical Device User Fee & Modernization Act, which reauthorizes the FDA’s ability to charge fees for product review, passed through the Senate and the House with sweeping support last month. The 2 chambers are reconciling their versions of MDUFMA before sending it to President Barack Obama’s desk.
Shuren told the crowd of life sciences representatives that CDRH is going through "culture change towards greater transparency, interaction and collaboration" to "ensure that our recommendations and decisions are consistent and predictable," the Memphis Daily News reported.
"Our vision, what we should be trying to do, is to ensure that patients in the U.S. have access to high-quality, safe and effective devices of public health importancem, first in the world," Shuren said.
The agency is taking steps to insulate its review system from political headwinds to ensure that medical device review times are short and reasonable, he added.
"The good news is we’re seeing the canary in the coal mine is actually singing these days," Shuren said. "As we start to then implement more of the things we have under way and have additional dollars under [MDUFMA], I think we’re heading in the right direction."
FDA commissioner Dr. Margaret Hamburg took to the stage recently to similarly defend the agency’s progress in addressing the complaints of many in the devices and drug industries – that the agency is slow, unpredictable and opaque.
In an interview at the TedMed health innovation conference last month, Hamburg said med-tech review in the U.S. is "as fast or faster" than in Europe.
