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October 21, 2015

AdvaMed Praises Senators Gardner & Donnelly on Introduction of HDE Expansion Bill

WASHINGTON, D.C. – JC Scott, senior executive vice president, government affairs, for the Advanced Medical Technology Association (AdvaMed), issued the following statement today after introduction in the Senate of legislation to expand access to innovative medical technologies for patients with rare diseases or certain pediatric conditions:

“AdvaMed commends Sens. Cory Gardner (R-Colo.) and Joe Donnelly (D-Ind.) for introducing the Rare Device Innovation Act, which will help more patients, including pediatric patients, with rare diseases and conditions have access to life-saving and life-enhancing medical devices and diagnostics.

“The legislation would double to 8,000 the current threshold of patients allowed to be treated by a medical device under FDA’s humanitarian device exemption (HDE) program. The HDE program is designed to encourage development of medical device treatments and diagnostics for diseases or conditions that impact very small patient populations, but it is currently limited to fewer than 4,000 U.S. patients per year.

“Doubling the current cap of 4,000 individuals would allow more patients to be treated under the HDE program and remove a significant disincentive which is hampering the development of devices for small pediatric populations and for rare diseases and conditions.

“We look forward to working with members of Congress, FDA and other key stakeholders to move this important legislation forward.”

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