Coverage
Transitional Coverage of Emerging Technologies (TCET)
Creating a clear and consistent pathway to coverage for new and innovative medical technologies will ensure Medicare patients’ access to life-saving and life-enhancing care.


Regulatory
MDUFA V
The fifth Medical Device User Fee Amendments reauthorization, MDUFA V, builds on and enhances the solid foundation previous agreements have built. MDUFA V comes at a pivotal time.
Device Repair
Third-Party Servicing of Medical Devices
Proper servicing of complex, life-saving and life-sustaining medical devices is vital to their safe and effective functioning and the safety of patients and device users.


Regulatory
Diagnostics Regulatory Reform
AdvaMedDx® supports the modernization of the regulatory framework for all clinical diagnostic tests to foster innovation, embrace scientific advances, and ensure swift access to accurate and reliable tests for all patients.

