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AdvaMed Commends Revised 21st Century Cures Package
WASHINGTON, D.C. – Scott Whitaker, president and CEO of the Advanced Medical Technology Association (AdvaMed), issued the following statement on the revised 21st Century Cures legislative package:
“AdvaMed commends House and Senate negotiators for coming to agreement on a revised legislative package which will do so much to accelerate the discovery, development and delivery of medical advancements for patients and strengthen the American innovation ecosystem.
“Patients are looking to medical technology companies to develop the next generation of life-saving, life-enhancing devices and diagnostics. These advancements are key to solving the nation’s health care challenges, as greater patient access to innovative technologies generates efficiencies and cost savings for the health care system while improving the quality of care.
“But the innovation ecosystem that supports the development of these technologies is severely stressed. Policy improvements such as those contained in the revised 21st Century Cures legislative package will help strengthen that ecosystem and support the development of life-changing medical technology.
“The package includes a number of important improvements to FDA’s medical device premarket program designed to increase the efficiency, predictability and transparency of the agency’s review process. The most significant of these builds on initiatives already underway within FDA to help create an expedited pathway for breakthrough medical technologies – those that offer the best hope for patients with life-threatening or irreversibly debilitating diseases or conditions who have no or limited alternative treatment options.
“We urge Congress to take action on this important legislation as soon as possible for the benefit of patients everywhere.”