Ambitious MDUFMA Goals Up For Discussion May 22
This article was originally published in The Gray Sheet
Executive Summary
Two ambitious but optional FDA performance goals for device premarket reviews will be up for discussion at a public meeting May 22
You may also be interested in...
More Needs To Be Done To Accelerate Device Reviews – von Eschenbach
Acting FDA Commissioner Andrew von Eschenbach said the agency needs to go beyond the "incremental" improvements it has made in speeding up the review of device premarket applications under the Medical Device User Fee & Modernization Act (MDUFMA)
AdvaMed President Ubl Sets Ambitious FDA Performance, International Goals
AdvaMed President Steve Ubl aims to have FDA meeting a 180-day review deadline for expedited PMAs in the next three to five years and to revamp Japan's reimbursement system in the next two years
EU Experts Want One-Stop-Shop EU Governance That Mimics Best Of Other Jurisdictions
It may be blue sky thinking to surmise how a new EU medtech regulatory governance structure could evolve. But with change on the horizon, experts see exciting opportunities.