When the Food and Drug Administration fails to approve or acts slowly on a potentially life-saving medical device, the result is needless deaths, says a new Cato Institute study.

• Reforms of the FDA passed earlier by Congress leave the agency's monopoly power over market access and dissemination of information intact.

• Certification powers should be turned over to third parties or certification organizations -- modeled perhaps on the highly successful Underwriters Laboratories, Inc., which has been certifying the safety of electrical equipment for more than 100 years.

• Although the new law directs the FDA to accredit individuals and companies to carry out third-party efficacy and safety review of some devices, the authority involves only the simplest and least innovative medical devices.

• The FDA retains the power to make final decisions about whether devices can be marketed.

The study cites FDA delays in approving a CPR device called the AmbuCardio Pump as being responsible for 7,000 needless deaths annually. Similarly, delays in approving Physio-Control's cardiac defibrillators caused 1,000 deaths.

Source: Noel D. Campbell (Gordon College), "Replace FDA Regulation of Medical Devices With Third-Party Certification," Policy Analysis No. 288, November 12, 1997, Cato Institute, 1000 Massachusetts Avenue, N.W., Washington, DC 20001, (202) 842-0200.