* 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 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
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.
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
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)