Minnesota delegation calls on FDA to cut red tape in review process for medical devices
Washington, D.C. - A Minnesota delegation of lawmakers sent a letter to the commissioner of the Food and Drug Administration (FDA) seeking an explanation for the increase of hurdles and delays faced by companies seeking approval for medical devices.
The delegation included U.S. Senators Amy Klobuchar and Al Franken and U.S. Representatives Erik Paulsen, Collin Peterson, John Kline, Betty McCollum, Keith Ellison, Michele Bachmann, Tim Walz and Chip Cravaack
The letter highlighted the importance of medical device companies to Minnesota's economy and pressed the FDA Commissioner Margaret Hamburg for answers on how to cut red tape that has led to a decline in the number of approved devices in the last year.
"U.S. medical technology companies have historically led the world with ground-breaking innovations that improve patient care. They are also a key force within the U.S. economy, providing well-paying jobs."
The letter continues, "While we support your mission of ensuring that safe and effective devices reach the marketplace, we feel that we can achieve that goal while still balancing our ability to develop innovative life-saving therapies."
The Minnesota delegation highlighted that over recent years, the percentage of medical devices approved during the first review cycle has declined dramatically. The letter emphasized the need to address these type of delays which lead to uncertainty and reduced investments in new products, as well as limiting their availability to consumers.