Reps. Todd Young and Scott Peters Introduce Bipartisan Legislation to Eliminate Duplicative Federal Requirement on Medical Device Companies

Congressmen Todd Young (R-IN) and Scott Peters (D-CA) introduced H.R. 4714, the Removing Barriers to Clinical Research Act to create parity in the treatment of medical device clinical trials versus that of pharmaceutical drugs. The legislation eliminates a burdensome, duplicative requirement that increases the length-of-time and costs associated with medical device research and development:

"Inefficiencies in this redundant federal approval process tie up resourcesand put medical device companies at a competitive disadvantage. For small Hoosier device manufacturers or startups, the increasing costs of growing a business in the United States can already be prohibitive. Added bureaucracy further discourages local investment and risks slowing device industry growth and job creation. By eliminating duplicative requirements, we'll speed up the rate of research into life-saving medical innovations and help guarantee Indiana's medical device manufacturing sector remains among the most competitive, fastest-growing in the world." --Rep. Todd Young (R-IN)

"Streamlining the federal approval process will reduce the wait times for patients to receive lifesaving medical devices. This bipartisan proposal will also allow San Diego's medical device industry to put more resources into developing new devices as it continues to grow our region's economy and create high-quality jobs." -- Rep. Scott Peters (D-CA)

"We applaud Representative Todd Young and Representative Scott Peters for their work on legislation to provide access to the latest medical device technology to patients sooner. Today, Medicare covers certain medical costs for patients participating in FDA-approved clinical trials. Although drug trials approved by the FDA automatically are covered by Medicare, medical device trials must go through a second coverage determination by a separate agency. This additional process adds both unnecessary time and cost to the conduct of medical device clinical trials and is especially challenging for small, start-up companies that do not have the resources necessary to navigate these bureaucratic hurdles." --Steve Ferguson, Chairman of Bloomington Based Cook Medical Group

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