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Klobuchar issues statement on FDA medical device proposals

Washington, D.C. - U.S. Senator Amy Klobuchar issued the following statement this week after Food and Drug Administration (FDA) released its implementation plan to reform the 510(k) medical device approval process:

"I am encouraged that the changes outlined by the FDA take a more balanced approach and include input from the medical device industry and other stakeholders. As the FDA moves forward with reforms that will impact the medical device industry, it is critical that any changes continue to allow our companies to create jobs, develop innovative products, and maintain patient safety."

Klobuchar is the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion, and she has met with FDA Commissioner Margaret Hamburg to discuss the medical device approval process.