ARTICLE SUMMARY:
The MDUFA V user fee reauthorization agreement is now in the hands of Congress. We highlight three recent Market Pathways stories tracking initial reactions from US lawmakers. Also inside: the European Medical Device Regulation has been in effect for a year, but trade associations in Germany and France argue that timelines need to be pushed back to avoid a regulatory and market crisis. And CDRH's Kevin Fu advocates a total product lifecycle approach to combat medtech cybersecurity risks.
