Should the medical device industry pay user fees to CMS?

Achieving reimbursement from payers has become a major challenge for medical device companies. Could the solution lie in having them pay user fees to CMS – the way they do to FDA? That was the question floated by Nadim Yared, president of CVRx and the current chairman of AdvaMed, during this week’s Medtech Conference powered by

Did Congress just kill medical device innovation?

The Medical Device User Fee Amendments bill that Congress passed this year is more than an FDA fees hike for device companies; it could inhibit innovation, says Michael Drues, a regulatory consultant based outside Boston. That’s because MDUFA 2017 includes new user fees – about $23,000 for small companies and $93,000 for large companies – for