The US Food and Drug Administration (FDA) has proposed the Innovation Pathway, a priority review program for new medical devices.
The program is designed to encourage cutting-edge technologies among medical device manufacturers.
The initiative will also seek to strengthen the nation’s research infrastructure for developing breakthrough technologies and advancing quality regulatory science.
The proposed actions of the programme include: establishing third-party certification program for US medical device test centres to promote new technologies, creating publicly available curriculum for medical device development, and using data collected outside the US.
As a part of the initiative, the FDA has also accepted the first submission: a brain-controlled, upper-extremity prosthetic from the Defense Advanced Research Projects Agency (DARPA), which will serve as a pilot for the programme.
Because of the transformative nature of the devices in the Innovation Pathway, FDA could conduct premarket reviews within 150 days, nearly half the time it currently takes FDA to review most premarket approval applications.
The FDA will seek further public comment before the Pathway can be used more broadly.