The Food and Drug Administration's guidelines call for approval of medical devices within 90 days of application if they are "substantially equivalent" to those in use. They call for approval of new devices within 180 days. However, regulatory delays that violate the guidelines have increased substantially since 1991, a year after David Kessler became FDA commissioner.

• In October 1994, 768 applications were awaiting approval past the 90-day deadline, compared to only two in November 1991.

• In 1992, only 12 new devices were approved, while hundreds of applications were delayed past the 180-day deadline.

Approval for medical devices takes two to three years in the United States, compared to six to eight months in Europe. A 1993 report by a House Energy and Commerce subcommittee said: "There is no evidence to indicate that products available in these major overseas markets are any less safe than products available in the United States." Nevertheless, the FDA has become increasingly strict. For example:

• A U. S.-developed portable "cardiac pump" for resuscitating heart attack victims has passed clinical trials and is standard ambulance equipment in cities around the world but is not approved for use here.

• A device called the Sensor Pad that allows women to detect lumps in their breasts the size of a grain of salt was approved in less than 60 days in Canada, but its inventor has spent nine years and $2 million unsuccessfully attempting to gain FDA approval.

• Dr. Richard Cummins of the American Heart Association estimates that 1,000 lives were lost when FDA red tape prohibited the manufacturer from selling a defibrillator even though the device had already been approved; the manufacturer finally had to go to court.

• Dr. Martin Kessler of Georgetown University Medical Center estimates that scores of babies died because FDA red tape prevented the use of specialized baby ventilators able to provide tiny breaths to sick infants.

While the FDA delays were occurring, the agency's staff grew from 7,600 to 8,700 and its budget increased from $598 to $760 million.

Source: Alan M. Slobodin, "...And People Die Waiting for FDA Approval," Consumers' Research, Vol. 77, No. 12, December 1994.