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Paulsen Provisions Included in House Passed FDA Reform Package

Press Release

Location: Washington, DC

Today, the House of Representatives passed a package of provisions aimed at reforming an often inefficient and bureaucratic Food and Drug Administration (FDA). Over the past two years, Representative Erik Paulsen (MN-03) has worked closely with fellow members to introduce the reforms. Many of the measures were championed by Rep. Paulsen, including those related to conflicts of interest, reaffirming least burdensome standards, requiring FDA to provide scientific rational for major decisions, incentives for humanitarian use devices, as well as his third party accreditation. These provisions were included in the package which passed the House by a vote of 387 to 5.

"The process for reviewing medical devices should be rigorous, but also relevant. This important legislation will streamline and modernize the medical device approval process to make it more transparent, more consistent, and more predictable. These much needed reforms will foster American innovation, increase patient access to life-saving technologies, and ensure product safety," said Rep. Paulsen.

Included in the bill passed today in the House was a reform authored by Rep. Paulsen in his recently introduced FDA REFORM Act. The provision would expand and clarify the FDA's ability to use accredited third party reviewers for low risk devices - freeing up valuable resources and allowing the FDA to function more effectively while still protecting patient safety.

Paulsen, a champion of small business and advocate of free enterprise, entrepreneurship, and innovation, currently serves on the House Ways and Means Committee. He is co-chair of the Congressional Medical Technology Caucus and the U.S.--Korea Free Trade Working Group.

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