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Public Statements

Food and Drug Administration Reform Act

Floor Speech

Location: Washington, DC


Mr. PAULSEN. Mr. Speaker, I rise today in strong support of H.R. 5651, the Food and Drug Administration Reform Act.

The United States has led the global medical device industry for decades. This leadership has brought hundreds of thousands of high-paying jobs to our country and life-saving, life-improving devices to our nation's patients. U.S. medical device-related employment totals over 2 million jobs, and these are good, rewarding jobs.

This legislation will streamline and modernize the medical device approval process to make it more transparent, more consistent, and more predictable. This much needed reform will help companies bring their products to market quicker and cheaper, ultimately increasing patient access to life improving and life saving technologies.

I would like to highlight one portion of the bill that was taken from my legislation, the FDA REFORM Act. This provision would expand and clarify the FDA's ability to use accredited third party reviewers for low risk devices.

This will free up valuable resources and allow the FDA to function more effectively while still focusing on protecting patient safety.

I want to thank Chairman Upton and his staff for their continued support and effort on this matter. I urge adoption of this crucial legislation that will help bring new products to market


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