The medical technology sector is one of the most heavily regulated industries. In recent years, there's been no shortage of policy challenges to the medtech sector including but not limited to the medical device excise tax, Medical Device User Fee & Modernization Act, sequestration of FDA user fees, and 510(k) rules modifications.  

MichBio is very active in helping to shape policy that impacts the medical technology innovator. MichBio serves as Chair of AdvaMed's State Medical Technology Alliance and is a member of MDMA's Medical Technology Regional Alliance. Both groups bring together all the medtech associations nationwide around common policy interests. In concert with those partners and others, MichBio advocates before the Congress, FDA, CMS, and other federal agencies that develop or implement policies that affect the medical device and diagnostics industry.

KEY ISSUES

Medical Device Excise Tax

Medical Device User Fee & Modernization Act (MDUFA) of 2012

Unique Device Identification (UDI)