U.S. FDA seeks faster review for novel devices

Tue Feb 8, 2011 11:52am EST

* Breakthrough medical devices could see 150-day review

* Proposal targets 'true pioneering technologies'

* FDA to host public meeting on proposal March 15

By Susan Heavey

WASHINGTON, Feb 8 (Reuters) - U.S. 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.

The announcement of the 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. [ID:nN07213534]

Obama has already boasted about the FDA's ability to more quickly review experimental devices. Since his FDA Commissioner, Margaret Hamburg, took office in mid-2009, the agency has made sweeping changes to its device unit, including how it reviews and classifies various devices.

Medical device makers include Boston Scientific Corp (BSX.N), Medtronic Inc (MDT.N) and Stryker Corp (SYK.N), among others.

The FDA said on Tuesday its 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 added.

It 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.

FDA said it will host a public meeting to discuss the proposal March 15 and accept public comments until April 12.

The proposal is online at link.reuters.com/myp87r . (Reporting by Susan Heavey; Editing by Tim Dobbyn)

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