FDA aims to accelerate medical device reviews

[February 09, 2011]  WASHINGTON (AP) -- Federal health officials are proposing a plan that would speed up the approval of innovative medical devices that have the potential to dramatically improve patients' lives.

The so-called Innovation Pathway, announced Tuesday by the Food and Drug Administration, would aim to review first-of-a-kind devices in five months, which is half the time currently spent reviewing most new devices. Under the program, the FDA would begin corresponding with device scientists in the early stages of development, helping them design studies to show the safety and effectiveness of their devices.

The initiative comes amid complaints from medical device manufacturers that U.S. review times lag behind other countries.

Medical device executives say it takes the FDA about twice as long to review new devices as their counterparts in the European Union, according to an industry survey released last month by PriceWaterhouseCoopers. Executives ranked the U.S. as the seventh slowest nation in terms of device approvals, behind India, Israel and European countries like France and Germany.

"European countries will continue to provide more supportive regulatory processes that encourage innovation yet ensure safety and effectiveness on a timely basis," the report concluded.

Medical devices represent a $350 billion global business, with most of the major companies based in the U.S., including Medtronic Inc., St. Jude Medical Inc. and Baxter International Inc.

The FDA said an innovative prosthetic arm developed by the Department of Defense would be the first device to use the new system. The device is remotely linked to a microchip in the brain that gives patients near-natural coordination of the prosthetic hand and fingers. It is intended for patients who have suffered spinal cord injury, stroke or amputation.

Makers of devices accepted into the new program will receive a written agreement from the agency with a target approval date and a roadmap for the reviewing the product. The devices will be reviewed by a special committee within the FDA made up of experienced scientists and managers.

The agency will hold a public meeting on the program March 15 to gather comments from the public.

Tuesday's announcement comes as the FDA pushes ahead with a multiyear effort to overhaul its 35-year-old system for approving medical devices, which has been subject to increasing criticism by public safety advocates.

Last month the agency announced a series of changes to the program, including streamlining the review process for some low-risk devices. But many significant changes favored by public safety advocates -- including specifying when the agency can revoke a device's approval -- were not included in the announcement. Those changes have been aggressively opposed by the medical device industry's lobbying arm, AdvaMed, which represents most of the largest device firms, including Boston Scientific Corp. and Johnson & Johnson. Those companies and several others have been forced to recall faulty products in recent years, attracting scrutiny from Congress.

The Medical Device Manufacturers Association, which represents smaller medical device companies, commended the FDA's innovation plan and urged the agency to continue addressing delays in device approval.

"Unnecessary and unreasonable delays for safe and effective products not only hurt innovation, they unfairly punish patients who are relying on America's med-tech entrepreneurs for help," said Mark Leahey, the group's president.

[Associated Press; MATTHEW PERRONE]

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