• By ICR Secretariat
  • Posted Wednesday, May 10, 2017

CDRH Forwards Alternate Path for Device Approvals

http://www.raps.org/Regulatory-Focus/News/2017/05/03/27472/CDRH-Plots-Path-to-New-Progressive-Approvals-for-Some-Devices/?mc_cid=474ff3f393&mc_eid=%5bUNIQID%5d

The FDA's Centre for Devices and Radiological Health have presented a new path to 'Progressive' approvals for Medical Devices. This would allow devices already registered in Europe to be bought to market in the US, although additional post-market data would be required. Speaking at the MedCon conference in Cincinnati, Jeff Shuren, Director of the CDRH, told attendees that the progressive approval pathway could apply to certain breakthrough devices.