The Food and Drug Administration on Tuesday proposed a new approval pathway for cutting-edge medical devices.
The proposal comes amid industry complaints that the U.S. medical device sector is losing ground to Europe, where devices are approved at least two years faster on average. Consumer groups however worry that easing the approval process could be dangerous for patients.
The proposal, outlined in a White Paper, proposes ways to "help accelerate and reduce the cost of development and regulatory evaluation of innovative medical devices safely and based on sound science."
• Establishing a voluntary, third-party certification program for U.S. medical device test centers designed to promote rapid improvements to new technologies during a product's development and clinical testing stages;
• Creating a publicly-available core curriculum for medical device development and testing to train the next generation of innovators; and
• Using more device experience and data collected outside the United States.
Also Tuesday, the FDA announced that it had accepted its test case for the program: a brain-controlled, upper-extremity prosthetic submitted by the Defense Advanced Research Projects Agency (DARPA). The agency is seeking public comment on the proposal before it can be used more broadly and has announced a public meeting on March 15.