Device Companies Dodge Controversial Changes at FDA
Medical-device makers led by Medtronic Inc. won’t face drastic changes to U.S. regulatory reviews as they had feared, at least not initially.
The Food and Drug Administration announced today 25 steps it intends to take in 2011 to ensure the safety of medical devices approved under the agency’s 510(k) program and to make the process more predictable for companies and investors. The list omits the most controversial of 55 proposals made in August by an internal agency task force, according to the FDA.
While companies say the 30-year-old review program is out- dated and inconsistent, lawmakers have criticized the FDA for not requiring substantial testing of new devices that developers claim are similar to existing products. The FDA plans to clarify when clinical studies are required and create a council of top FDA experts to guarantee timely and predictable decision-making.
“We are encouraged by what we saw come out of the FDA,” William Hawkins, Medtronic’s chief executive officer, said in a telephone interview today. “This is a much more balanced outcome than what we feared at the onset.”
Medtronic fell 46 cents, or 1.2 percent, to $37.25 at 3:25 p.m. in New York Stock Exchange composite trading. The Minneapolis-based company is the world’s largest maker of heart devices.
3,000 New Devices
About 3,000 new devices are cleared each year through the 510(k) program by demonstrating they are at least as safe and effective as legally marketed products for the same use. These applications rarely require tests in people, and they make up 90 percent of device approvals, according to a Government Accountability Office report in 2009.
Fifteen of the 55 proposals the FDA announced last year were met with “significant concern” in public comments, according to the agency. Seven of these were turned over to the Institute of Medicine for review as part of a separate evaluation of the device program due in mid-2011.
“We felt it was important to allow for additional opportunities for discussion,” said Jeffrey Shuren, director of the agency’s Center for Devices and Radiological Health, on a conference call today with reporters. Concerns were raised by patient groups and doctors on some of the proposals, not just by industry, he said.
The FDA asked the Institute of Medicine to weigh in on proposals to establish a new category of medium-risk devices, require post-approval surveillance studies for clearance of certain equipment, and issue guidance on when older devices should no longer be used as a standard for approval.
Public Meeting
Four of these recommendations will be considered on a case- by-case basis and three will receive additional input from industry. Two of these proposals -- posting photographs of devices online and creating an online database of labeling information -- will be discussed at an April 7-8 public meeting.
“The announcement amounted to a non-event as decisions and/or details around the most controversial proposals were delayed until a later date,” said Derrick Sung, an analyst at Sanford C. Bernstein & Co. in New York, in a note to clients. “Overall, we think there is little that can be read over from the news that was released today.”
To contact the reporters on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net; David Olmos in San Francisco at dolmos@bloomberg.net.
To contact the editor responsible for this story: Reg Gale at rgale5@bloomberg.net.
Rate this Page