FDA regulation of biomedical software

A major problem faced by biomedical software developers and users is the complexity of the regulatory regimes confronting them. Of particular concern is whether, and to what extent, they are regulated by the Food and Drug Administration (FDA) and the consequences of such regulation. Producers, distributors, and users of biomedical software often are unaware that FDA regulates many of these products as medical devices. Developers, vendors, distributors, or users of such software are subject to significant civil and criminal liability for noncompliance. This article explains the current regulatory requirements imposed on computer software developers and users by FDA, biomedical and some proactive strategies for avoiding adverse enforcement.