U.S. Senator Amy Klobuchar released the following statement today after the Food and Drug Administration (FDA) announced a new program to support groundbreaking medical devices and encourage cutting-edge technology and innovation in the industry:
"Innovation has always been vital to the success of the U.S. medical device industry. It is critical that we have processes that promote pioneering technologies that improve, extend, and save countless lives. The FDA's action to streamline the regulatory approval process is a good first step to help promote the great innovations of tomorrow for Minnesota entrepreneurs and medical device manufacturers
"As we move forward, I will continue to push the FDA to address delays and inconsistencies in the approval process, including the 510k process, and I will continue to talk to Minnesota businesses to fight for reforms that protect patients without stifling new health care breakthroughs."
As the chair of the Senate Commerce Subcommittee on Competitiveness, Innovation, and Export Promotion, Klobuchar has met with FDA Commissioner Margaret Hamburg to discuss the medical device approval process andpushed the FDA to establish a more efficient and predictable regulatory system that will help bring life-saving technologies to the market.