FDA Device Chief Open To New Review Approaches For Novel Technologies
This article was originally published in The Gray Sheet
Executive Summary
FDA device center director Jeffrey Shuren says the idea of creating a special review pathway for novel technologies is gaining momentum at CDRH.
You may also be interested in...
FDA And CMS Parallel Reviews Will Begin With Device Pilot Program
FDA and CMS' consideration of parallel medical product reviews will begin in earnest with a planned pilot program for devices, the agencies say
VC Firms Seek New FDA Review Path, User Fee For "Novel" Devices
The National Venture Capital Association is in discussions with senior CDRH officials about establishing a separate, more efficient pre-market review pathway for especially novel devices, supported by a supplemental user fee
Second EU MDR Notified Body Designated In France
Four years after the designation of the first notified body in France under the Medical Device Regulation, AFNOR Certification has been named too.