The Food and Drug Administration is set to revise medical software regulations, and that reportedly has sent manufacturers into a panic.

• Experts classify medical software into four categories, ranging from basic information -- such as online textbooks -- to "high-risk" software that could, for example, measure a patient's current conditions and automatically adjust drug doses or other treatments.

• Under current rules, the FDA basically treats medical software in the same way it treats a medical device like a pacemaker or an artificial limb. But now it wants to revise its gudelines to cope with the explosion of medical software systems.

• Industry experts fear the FDA might stifle innovation in this growing industry.

• They warn of a "potential catastrophe" if existing policies toward hardware devices are applied to software devices.

Under medical device rules, certain changes to a device have to be FDA approved -- but since software systems are changed daily, the industry says it cannot wait 90 days for FDA approval.

Source: John Merline, "FDA Eyes New Medical Software Rules; Industry Wary," Investor's Business Daily, October 31, 1996.