Novel health devices could see faster reviews
New guidelines would allow FDA to review new medical devices within 150 days and allow for voluntary certification for companies to speed up the review process.
Tue, Feb 08, 2011 at 02:43 PM
QUICK APPROVAL: Proposed FDA guidelines would allow the agency quicker approval time for new devices, like arm and hand prostheses. (Photo: ZUMA Press)
WASHINGTON, D.C. - Health regulators are seeking to speed up their reviews of promising medical devices and boost research for new technologies in hopes of getting novel products to market faster.
The initiative targets "devices that are true pioneering technologies and that have the potential to revolutionize patient care or health care delivery," the Food and Drug Administration said on Tuesday.
Its first candidate is an artificial arm from the Department of Defense's Defense Advanced Research Projects Agency that uses a microchip in the brain to control the device's arm, hand and finger function.
The proposed changes "will help accelerate the development of and patient access to innovative medical devices, which often fulfill unmet public health needs," Jeffrey Shuren, head of FDA's Center for Devices and Radiological Health, said in a statement.
Shuren told reporters, however, that the agency could only handle about one or two such expedited reviews a year and that funding the initiative would be an issue as Congress looks to renew device industry user fees that expire in 2012.
The announcement of the proposed program comes a day after President Barack Obama stepped up efforts to woo the U.S. business sector, pledging to eliminate burdensome regulations and taxes.
"This initiative has broad implications for how the FDA does business and how we support and will continue to support important opportunities for innovation," FDA Commissioner Margaret Hamburg echoed in comments to reporters on Tuesday.
Obama has already boasted about the FDA's ability to more quickly review experimental devices. Since Hamburg took office in mid-2009, the agency has made sweeping changes to its device unit, including how it reviews and classifies various devices.
Critics have long said the agency needed to pay closer attention to medical devices, which can range from simple bandages to complicated heart defibrillators. Quick or nonexistent FDA reviews as companies tweak their devices can have safety implications, they have warned.
But the industry has said closer or more tedious reviews could hamper new products.
Last month, FDA officials announced steps to help streamline its device review but sidestepped several outstanding issues in what was largely seen as an industry win.
Medical device makers include Boston Scientific Corp, Medtronic Inc and Stryker Corp, among others.
The FDA said on Tuesday its latest plan would allow the agency to review promising devices within 150 days. Agency staff would devote more time and resources earlier in the review process to make its oversight more efficient, it said.
FDA also called for more research into novel technologies that would include a voluntary certification program to help test new devices quickly and speed their development.
In a statement, the device industry's lobbying group, the Advanced Medical Technology Association, applauded the proposal and said it would discuss it with the agency.
FDA said it will host a public meeting to discuss the proposal March 15 and accept public comments until April 12.
On the Web: FDA proposal
(Reporting by Susan Heavey; Editing by Tim Dobbyn and Richard Chang)
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