FDA, trade group to speed up approval for medical devices

An organization representing Minnesota's medical technology companies will work with the Food and Drug Administration to improve the process for approving medical devices.

LifeScience Alley expects to sign a memorandum committing the business group, FDA and academic experts to work together to refine the procedures, practices and science for approving medical devices.

The trade group will formalize the agreement with the FDA on Wednesday during its 10th annual conference.

"The fundamental reason for doing this is to establish a common understanding of the state of the art as regards the design, development and testing of medical products,"said Dale Wahlstrom, president of LifeScience Alley.

Medical technology companies criticize the device approval process as slow, confusing and expensive. Critics of the FDA say the agency has not been tough enough in reviewing devices before they go to market.

Medical technology firms want a review process that is transparent and understandable, Wahlstrom said.

"We can improve predictability through greater understanding, greater clarity," Wahlstrom said. "Any time you're dealing with a medical product, there's always risk involved one of the primary goals and objectives of this is to manage risk in a more efficient and effective manner that makes both regulators and manufacturers comfortable."