Home » US FDA Looks to Europe for Ideas to Improve Its 510(k) Process
US FDA Looks to Europe for Ideas to Improve Its 510(k) Process
November 13, 2009
The U.S. Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) may incorporate aspects of Europe’s CE Marking
approval rules in its 510(k) clearance process, FDA Principal Deputy Commissioner Joshua Sharfstein says.
To View This Article:
Subscribe To International Medical Device Regulatory Monitor