Tag Archives: Medical device

Dialysis is the FDA hotbed, once again

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There’s a new program at the US Food and Drug Administration.  One designed to afford innovative devices a speedier review process. This Innovation Pathway 2.0 program is designed for pre-market evaluations of medical devices, expediting the process without reducing the need or quality of safety and effectiveness reviews.  And some 30 years ago, there was a similar process for smaller companies- it worked, then, too.  (I know, we used it- twice!)

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