Coverage
Patient Access to Breakthrough Devices
FDA designates certain medical devices serving unmet needs as “breakthrough” and gives manufacturers expedited feedback to earn the authorization needed to make the technology available to patients. However, Medicare often takes years to cover procedures involving those FDA-authorized technologies, forcing patients and their doctors to wait. AdvaMed supports policies that get proven medtech to patients faster.
Small Business
Supporting Small Innovators (SBIR)
Federal SBIR and STTR grants give small medtech businesses and startups the early-stage funding they need to turn breakthrough ideas into lifesaving technology. AdvaMed fought for the programs’ reauthorization and continues to advocate for their strength.
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.
Trade
Supply Chain
AdvaMed® forges partnerships to ensure the delivery of healthcare is a priority amidst widespread upstream shortages and transport disruptions.
Response
Relief Response
In times of crisis, the medtech industry stands as a pillar of strength, providing innovative solutions to address immediate needs and foster resilience. Discover a few NGO’s that AdvaMed® members can partner with to help make a positive impact around the world.
Additional Key Issues
Beyond our core priorities, AdvaMed continues to advocate on a range of issues affecting medical technology, patient care, and the health care system. Browse the topics below to see our latest positions and resources.