Jan. 15 (Bloomberg) -- Medical devices have been approved for sale by the U.S. Food and Drug Administration without proof they work or are safe, a government report found.

The FDA required extensive testing for less than one-tenth of the devices it cleared from 2003 to 2007, according to a report today by the Government Accountability Office, the investigative arm of Congress. The agency called for “immediate steps” to bolster scrutiny of products posing the greatest risks, including artificial hip joints and heart pacemakers.

FDA leaders have repeatedly been criticized by staff members who say bosses force them to back products without scientific evidence. A group of agency scientists called reviews of medical devices “corrupted and distorted” in a Jan. 7 letter to lawmakers and President-elect Barack Obama.

“It’s outrageous that the FDA is cutting corners in the review process,” Representative Frank Pallone Jr., a New Jersey Democrat, said today in an e-mailed statement. “It’s time the FDA abide by the intent of the law so that we can ensure that all medical devices are safe.”

The GAO report focuses on so-called Class III medical devices, those that are essential to health or pose an unreasonable risk of injury of illness. The FDA has been slow to implement a 1976 law requiring that all new products in this group undergo a strict review. Instead, many are cleared with minimal tests if companies can prove them “substantially equivalent” to existing products.

The FDA Amendments Act of 2007 required that the GAO report to Congress whether there was “appropriate use” of the process that allows the minimal reviews.

FDA Agrees

The Health and Human Services Department, which oversees the FDA, agreed with the recommendations, but didn’t say when it would make the changes, the GAO said.

AdvaMed, a Washington-based trade group representing makers of medical devices, supports the GAO’s recommendation that the FDA complete its review of class III devices and decide which need stricter approval standards and which are safe enough to be moved to the less-stringent class II category.

FDA scrutiny, while costly and time consuming, helps companies because it “assures and communicates that the benefits of the technology outweigh the risks,” said Susan Alpert, senior vice president and chief regulatory officer for the device maker Medtronic Inc., in a phone interview today, speaking for her company and AdvaMed.

Pallone, chairman of the health subcommittee of the House Energy and Commerce Committee, said he’ll hold hearings and might introduce legislation to spur the FDA into action.

The report likely “only skims the surface of the problems that plague FDA’s medical device program,” said Representative Henry Waxman, a California Democrat who chairs the House Energy and Commerce Committee, in an e-mailed statement. “Americans deserve to have confidence that when FDA allows a medical device to go on the market it will be safe and effective.”

To contact the reporter on this story: Catherine Larkin in Washington at clarkin4@bloomberg.net.

Last Updated: January 15, 2009 17:46 EST