Makers of medical devices will face tougher approval standards under new guidelines being developed by the U.S. Food and Drug Administration.
In the face of two studies critical of the FDA's approval processes, an agency official told The New York Times that it will urge manufacturers to develop well-defined targets for their trials on humans and measure them more closely.
Dr. Jeffrey Shuren, acting director of the Center for Devices and Radiological Health, told The Times that in late 2007 the agency started making improvements, which included a checklist for gauging the scientific merits of manufacturers' proposed designs. But he said he expects the agency will put out guidelines in the next year with explicit expectations regarding the scientific data that manufacturers present in clinical studies.
His comments preceded Tuesday's release of two studies that found the approval processes for high-risk heart devices such as coronary stents, pacemakers and implanted defibrillators suffered from a lack of high-quality data. Both studies reviewed clinical trials submitted for FDA approval from 2000 to 2007.
One study was conducted by the FDA and researchers from the Beth Israel Deaconess Medical Center in Boston. The other, published in The Journal of the American Medical Association, was led by researchers at the University of California, San Francisco.
The FDA-led study found enough problems with the quality of data submitted to warrant making policy changes, Shuren said. "It is not acceptable, and that is the reason we are making the changes in the program we are making," he told The Times.