Some medical devices could move through the Food and Drug Administration approval process faster under changes in the 510(k) program the agency announced today.
FDA moves to speed device approval process
For instance, the agency plans to streamline the “de novo” review process for certain innovative, lower-risk medical devices and establish a new Center Science Council of senior FDA experts to ensure timely and consistent science-based decision making. Those initiatives are part of a 25-point plan the FDA intends to implement in 2011 to expedite approvals for most types of medical devices.
These actions will result in “a smarter medical device program that supports innovation, keeps jobs here at home, and brings important, safe, and effective technologies to patients quickly,” said Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, in a news release.
The plan drew support from at least one industry group.
“The plan is clearly a good first step that will address some of the major problems with the program, including improving consistency, providing greater reviewer training, and streamlining of the de novo process,” wrote Stephen Ubl, president and CEO of AdvaMed, in a news release.
Ubl expressed relief that the FDA plans to drop more controversial actions it was considering, including some that would have created “significant burdens” for the medical device industry.
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