The Safe Medical Devices Act of 1990: new directions for FDA software regulation

An analysis of the effect of the 'safe medical devices act' (1990) on nonembedded software which interacts directly with medical devices is presented. Such devices include laboratory analyzers, image generators, therapeutic machinery, and patient monitors. Nonembedded software might interact with such devices across a computer network. Typical nonembedded software includes clinical laboratory systems, radiology systems, and intensive car systems. These systems are chosen for analysis because changes in the regulatory system make them much more vulnerable to legal action under the 1990 act than under the original 1976 act. The analysis shows that up to this time many producers of nonembedded device connecting software have not complied with the food and drug act, and the FDA had the authority, but not the tools to compel compliance. The 1990 act gives the FDA the data collection and enforcement tools to track down unregistered manufacturers of device connecting software.<>