Minnesota senators focus on FDA medical device approval

Les sénateurs du Minnesota se concentrent sur l'approbation médicale de dispositif de FDA

par Astrid Fiano, DOTmed News Writer | August 26, 2010
Senator Franken
Minnesota Senators Al Franken and Amy Klobuchar have both recently addressed the challenges facing medical device manufacturers in the FDA approval process.

Last month, Klobuchar met with FDA Commissioner Margaret Hamburg to discuss the need for balance in the 501(k) program. On Monday, Klobuchar continued her advocacy for improving the device approval process in a keynote address to a conference for members of the medical devices and health care industries. The conference in Minneapolis was sponsored by LifeScience Alley, a trade association.

"Minnesota is a national leader in the health care community, setting the standard for high-quality, affordable patient care," Klobuchar said. "The medical device industry will help us continue to build a health care system that is streamlined, innovative, and able to harness the power of technology."

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According to a press release, Klobuchar said consistency and predictability in the 510(k) approval process is vital, and recommended policies to balance product safety and product development. Klobuchar has expressed concerns that changes in the approval process for medical devices have led to a drop in venture capital investment in the industry.

Senator Franken has also been concerned over the approval process. DOTmed reported on Franken raising issues in a Health, Education, Labor and Pensions Committee Hearing on why medical devices manufacturers did not have as many incentives to create treatments for rare diseases as drug manufacturers have. Last Friday, Franken met with medical device company officials regarding their concerns over the device approval process. According to Franken's press release, Minnesota has over 400 medical device companies employing over 30,000. Franken is planning to meet with Commissioner Hamburg in the next month to discuss the 501(k) process.

"From hip replacements to pacemakers and hearing aids, some of the most pioneering ideas in the medical device world start right here in our backyard," Franken said in the release. "I'm committed to bringing the concerns of Minnesota's medical device companies to the FDA so that we remain a national and global leader in medical device innovation, and to keeping the jobs the industry creates in our state."

Adapted from press releases from Senators Klobuchar and Franken. The releases can be accessed here and here.