The 1990 Medical Device Amendments to the Food and Drug Act have caused a significant change in the regulation of medical software. The 1990 Act replaces the prior emphasis on premarket approvals with an emphasis on postmarket surveillance. Hospitals and other institutional users are now required to report to the FDA product defects that cause injuries or death. They are also required to report product defects to the manufacturer. The Act provides for rapid suspensions of device approval, recalls of defective products and civil penalties for violators. The combination of these factors may lead to enhanced FDA supervision of the purchase and use of medical software, and particularly an emphasis on finding unregistered producers. In addition, the new Act will have a direct effect on the regulation of software, because it is much better suited to addressing the problem of software quality than the 1976 Act.
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