FDA charts a new path to device approval

The Food and Drug Administration has proposed a new way for breakthrough medical devices to be approved by the agency.

In a briefing Tuesday, agency officials said the new Innovation Pathway is part of an initiative designed to help cutting-edge products win quicker clearance -- a huge issue in Minnesota, home to more than 300 med-tech companies, including industry giant Medtronic Inc.

Many industry officials charge that the FDA's approval process is inefficient and unpredictable.

FDA device chief Dr. Jeffrey Shuren said the new pathway "isn't an ordinary proposal and not the usual from a regulatory agency." Noting the agency's approval process has historically been "reactive," Shuren characterized the new initiative as "a sea change in the way we approach public health."

Med-tech officials reacted cautiously to the FDA proposal Tuesday. Stephen Ubl, who heads the Washington, D.C.-based trade association AdvaMed, said it will "carefully review the specifics" of the initiative.

"We believe it is critical that FDA maintain its focus on bringing greater speed and consistency to the current review process," said Ubl, a Minnesota native. The problems with the process "needlessly delay patient access to life-saving, life-enhancing medical technology," he added.

Steve Anderson, president of now-defunct Acorn Cardiovascular, said the med-tech industry needs "to see concrete progress at the reviewer level of the FDA, and not just at the policymaker level. To date, there is no indication of progress at that level within the agency."

The new Innovation Pathway calls for the FDA to get involved early with companies developing a novel product. A case manager would be assigned to each product, and the Center Science Council within the FDA would monitor its progress. A "road map" and timeline would be developed, as well.

The program would be used for a relatively small subset of medical devices -- those offering a significant improvement over current treatments, treat a life-threatening disease, address an unmet public health need or address a national security issue.

FDA officials predict that pre-market reviews of products under the new pathway could occur within 150 days -- nearly half the time it currently takes.

The first product undergoing the new approval pathway is a prosthetic arm for patients suffering from spinal cord injuries, stroke or amputation. Funded by the Defense Advanced Research Projects Agency, movement of the experimental arm is controlled by a microchip implanted in the brain.

Thomas Gunderson, senior medical technology analyst at Piper Jaffray & Co., said the initiative "is a step in the right direction. Still, the program needs to be implemented and most importantly suitably funded to a level that can make a difference for product timelines."