Perspective: CDRH’s Innovation Pathway: Will It Get Your Device to Market Faster?

Posted 01 August 2011 | By Kirsten Paulson, RAC 

In February 2011, US Food and Drug Administration (FDA) Commissioner Margaret Hamburg announced a new review program intended to put medical devices with revolutionary potential on a prioritized and accelerated review track. The Innovation Initiative will be headed by Jonathan Sackner-Bernstein, who will be the first to fill the role of associate director of technology and innovation. This initiative establishes the Innovation Pathway, an alternative to the typical Investigational Device Exemption-Premarket Application (IDE-PMA) pathway for regulation of new devices.

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