Trade group signs with FDA to improve medtech approval process

The Food and Drug Administration today pledged to work with Minnesota companies to improve evaluation of medical devices before they go to market.

LifeScience Alley, the trade group for Minnesota medtech firms, signed a memorandum of understanding with the FDA's Center for Devices and Radiological Health. The agreement commits the FDA and the members of LifeScience Alley to develop clearer and faster procedures for the FDA's review of medical devices.

"It's about developing the tools to figure our which devices are safe and effective," said Dr. Jeffery Shuren, who oversees the FDA division responsible for medical devices. "It's about advancing the science in support of assessing medical devices.

Medical device companies say the FDA process for reviewing medical devices has been slow, costly and unpredictable. FDA critics charge the agency has not been stringent enough in its reviews of medical devices.

"The intent here is about reducing the time and cost to develop, assess and review medical devices, so we can bring important technology to patients more quickly but with robust data to know that in fact they are going to benefit patients," Shuren said.