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Public Statements

Sen. Franken's Medical Device Approval Measures Signed into Law by President Obama

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Today, President Barack Obama signed into law an FDA Reauthorization bill that includes three key provisions U.S. Sen. Al Franken (D-Minn.) championed that will get life-saving medical devices to patients more quickly and safely. Sen. Franken - who, as a member of the Senate Health Committee, helped craft the overall legislation - issued the following statement after the President signed the Food and Drug Administration (FDA) Safety and Innovation Act.

"I'm pleased that President Obama signed this bill into law because it will mean that Minnesotans will have faster, safer access to innovative and potentially life-saving medical devices," said Sen. Franken. "I'm especially happy that the law includes my provisions that will improve the way medical devices get to the patients that need them. I'm proud that Minnesota is a world leader in developing life-saving medical devices, and I'll continue to work toward a more transparent and predictable FDA approval process."

Sen. Franken was a key member of a bipartisan group of Senate Health Committee members that authored the bill. Additionally, he championed three significant provisions that were included in the legislation passed by the Senate. The first was a provision that would allow the FDA to tap a deeper well of expertise from the medical device industry during the approval process, allowing devices to get to market more quickly. The second would encourage medical device makers to develop treatments for rare diseases, making it easier for patients with those diseases to get treatment. Sen. Franken's third provision would require that the FDA withdraw guidance released by the FDA that could have created new and burdensome requirements for companies making changes to their approved devices, which would cause even more delays.


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