FDA’s Expedited PMA Pathway Proposal: To Expand Or Contain? :: Medical Device News from “The Gray Sheet” :: Pharma & Medtech Business Intelligence

FDA’s Expedited PMA Pathway Proposal: To Expand Or Contain? :: Medical Device News from “The Gray Sheet” :: Pharma & Medtech Business Intelligence: "As FDA moves to establish an accelerated development program for breakthrough devices, it is getting diverging input on how expansive the program should be. Industry insists that the agency is thinking too small, while others say FDA must take care to ensure the program is limited and tightly controlled."