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FDA Bill Passes, Includes Sen. Brown's Proposal To Streamline Medical Device Regulations

Press Release

Location: Washington, DC

U.S. Senator Scott Brown (R-MA) released the following statement after the Senate passed the Food and Drug Administration (FDA) Safety and Innovation Act (S. 3187), which now heads to the president's desk for his signature:

"The overwhelming bipartisan support for this legislation is heartening, and stands as a testament to what we can accomplish when we set aside partisan bickering and focus on solving problems. In this case, bipartisanship means that the FDA now has the resources it needs to guarantee Americans have access to the safest, most advanced medical treatments possible. Just as important, the industry now has the certainty it needs to continue investing in research and creating new therapies and devices."

The Food and Drug Administration Safety and Innovation Act reauthorizes the Prescription Drug User Fee Agreement and the Medical Device User Fee Agreement for five-years, and also provides five-year authorizations for two new user fee programs, the Generic Drug User Fee Agreement and the Biosimilar Drug User Fee Agreement.

S.3187 includes a number of provisions aimed at improving regulation of medical devices, including a proposal championed by Senator Brown that will streamline the regulatory pathway for moderate risk medical devices and allow new products to reach patients faster. Specifically, Senator Brown's proposal improves the de novo classification process by striking the requirement that an applicant submit a 510(k) application before entering the de novo process, making the process more efficient and saving innovators valuable resources.

S.3187 also includes language based on S.606, the Creating Hope Act, which Senator Brown introduced with Senator Casey (D-PA). This language establishes a priority review voucher program to incentivize the development of treatments for pediatric rare diseases.

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