In a Feb. 8, 2011 news release, the Food and Drug Administration (FDA) announced its proposed Innovative Pathway initiative. The program is designed to shorten the FDA approval process for "new, breakthrough medical devices."
According to the release, the initiative will seek to "strengthen the nation's research infrastructure for developing breakthrough technologies and advancing quality regulatory science." Proposed actions include:
Establish a voluntary, third-party certification program for medical device test centers to expedite the approval process
Make curriculum and testing for device development available to the public
Use more global experience and information
To be considered for the program, a device would have to entail "truly pioneering technologies with the potential of revolutionizing patient care of health care delivery."
Medical device lawyer John Duane says this could potentially open loopholes for medical device manufacturers and negatively impact consumers. "Manufacturers may try and take advantage of the FDA's poor oversight in an effort to squeeze their device into the definition of a truly pioneering technology to take advantage of the fast track." Duane says, according to the initiatives, these devices could also be immune from state law causes of action for design defects.
The pilot device is a robotic arm developed by the Defense Advanced Research Projects Agency (DARPA).
The Center for Devices and Radiological Health (CDRH) will also be seeking public comment on the proposal and will host a public meeting in White Oak, Md. on March 15, 2011.
For more information on the program, visit the FDA's website.
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