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|Scott Whitaker (CEO) |
Nadim Yared (Board Chairman)
AdvaMed, or the Advanced Medical Technology Association, is an American medical device trade association, based in Washington, D.C. It is the largest medical device association in the world with U.S. and international members who are medical technology companies (medical devices, diagnostic products, and health information systems) that collectively represents 80% of U.S. medical technology firms in the United States, that produce close to 90% of annual health care technology purchases in the United States and more than 40% globally.
AdvaMed’s website states that the organization promotes competitive policies that foster the highest ethical standards, rapid product approvals, appropriate reimbursement, and access to international markets.
The Innovation Agenda identifies five core policy pillars: improving the FDA’s regulatory processes, restructuring CMS’s coverage and payment processes, reforming the U.S. tax system to create a level playing field, improving access to international markets, and supporting the maintenance and growth of an R&D infrastructure.
Medical Device Tax
AdvaMed has consistently and strongly opposed the 2.3% medical device excise tax imposed by the Affordable Care Act in 2013, stating that it harms job creation, deters medical innovation needed to save and improve patients’ lives, and inhibits economic growth.
In 2015, Congress temporarily suspended the medical device excise tax. While AdvaMed supported the suspension, the association continues to push for full and permanent repeal of the tax. Whitaker has stated that “It’s not enough to delay or further suspend this disruptive tax, even if for a longer period of time. It simply does not give industry the certainty and confidence it needs to make these critical long-term R&D investments. The time is now. We stand ready to help this administration, Congress, and the nation get Americans back on the job."
In February 2017, AdvaMed released data from the U.S. Department of Commerce revealing that the U.S. medical technology industry saw its jobs ranks fall by nearly 29,000 while the medical device excise tax was in effect.
AdvaMed and FDA's Finalized Human Factors Guidance for Combination Products
In 2016, the FDA released the first draft of its guidance on applying human factors engineering principles to combination products. It immediately faced criticism from AdvaMed, citing overly burdensome requirements. Seven years later, in 2023, the FDA finalized its guidance and released the final draft. It is intended to complement the FDA's 2011 device guidance and a separate document on "Safety Considerations for Product Design to Minimize Medication Errors." The finalized guidance addresses specific questions that may arise during the development of combination products, focusing on user interactions and clinical trials support.
In August 2020, The Advanced Medical Technology Association (AdvaMed) reported that VentConnect is growing its network. The updated MedDeviceNetwork network (MedDeviceNetwork.org) would expand past ventilators and incorporate many emerging medical devices in the current battle against COVID-19 and other potential health crises that America's doctors and caregivers require.
- "Member Organizations | FDA Medical Device Industry Coalition". FMDIC. Retrieved June 25, 2018.
- "AdvaMed Names Scott Whitaker CEO and President". PRnewswire. February 18, 2016. Retrieved June 25, 2018.
- "Report: CVRx CEO Yared tapped for AdvaMed chairman". Mass Device. June 27, 2016. Retrieved June 25, 2018.
- "About AdvaMed". AdvaMed. Retrieved June 25, 2018.
- "Innovation Agenda". AdvaMed. Retrieved June 25, 2018.
- "Surveys Illustrate Positive Results of Device Tax Suspension". Your online source for medical device product information - Medical Product Outsourcing. January 10, 2017. Retrieved June 25, 2018.
- Arundhati Parmar (February 8, 2017). "Medtech lobby says 29,000 jobs were lost while device tax was in effect". MedCity News. Retrieved June 25, 2018.
- Paul Taylor, Nick. "FDA finalizes combination product guidance 7 years after sharing draft".
- "AdvaMed expands VentConnect platform to advance production of COVID medtech". dotmed. 3 August 2020. Archived from the original on 2020-09-18. Retrieved 26 August 2020.
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