Better Review Process Should Be Goal of MDUFA Reauthorization

Devicemakers want a quicker and more consistent review time to be part of the Medical Device User Fee Act (MDUFA) when it is renewed in 2012. “Some venture capitalists are reporting that the FDA process has become so uncertain and arbitrary that they no longer invest in start-up companies until the company’s product has received FDA approval,” AdvaMed says in a comment on what should be included in the next MDUFA. As a result, the current device review process is “effectively stifling new product development and choking off the funding needed to develop tomorrow’s breakthrough treatments,” the trade association adds.
Devices & Diagnostics Letter