August Monthly Topic:

FDA Regulation of Decision Support Software

Decision support software is playing an increasing role in assisting health care professionals in the management and monitoring of patients.  These tools can vary widely, from programs that automate calculation of a drug dose that is ordinarily performed manually by healthcare professionals, to monitoring and directing therapy decisions based on predefined parameters.  The Food and Drug Administration’s (“FDA” or “agency”) regulation of decision support software programs, many of which are stand-alone software programs, may be departing from past agency policy.  Coupled with the lack of current, formal guidance, manufacturers of these software tools are finding it increasingly challenging to determine the regulatory status of these products.  In addition to commercial versions, these programs are often developed and deployed in-house at hospitals and other healthcare institutions.  Such entities will also need to assess the regulatory status of these tools, as the manner in which such tools are implemented and distributed throughout a hospital or institution may have FDA regulatory implications.  

In 1989, FDA issued a Draft Policy for the Regulation of Computer Products (“Draft Policy”) (November 13, 1989), which set forth the principles of how the agency would regulate computer products, including computer software.  Under this Draft Policy, which was never finalized, software which was previously not classified as a medical device was exempt from the Federal Food, Drug, and Cosmetic Act’s (“FD&C Act”) 510(k) premarket notification requirements if that software was intended to involve “competent human intervention” before any impact on human health occurs.  Ordinarily, this intervention was deemed to be present where clinical judgment and experience is used to confirm and interpret a system’s output.  Agency practice had also been to exempt such products from the requirements for establishment registration, device listing, medical device reporting (“MDR”), and the Quality System Regulation (“QSR”).

In 1996, FDA held a Software Policy Workshop (“Policy Workshop”) regarding the determination of whether unclassified computer products, including software, should be treated as accessories to medical devices or as stand-alone software for regulatory purposes.  The same general principles expressed in the Draft Policy regarding the regulation of stand-alone software and the “competent human intervention” exemption were reiterated at the Policy Workshop.  In addition, FDA defined stand-alone medical software as “medical software which is neither a component nor an accessory to another device, and which is intended to receive medically related data as input, and to output (relay) the results to a health care practitioner or other user.” 

While the Draft Policy and Policy Workshop offer insight into the agency’s past direction and intentions with respect to the regulation of stand-alone software programs, the Draft Policy has recently been officially withdrawn, and the agency has not issued guidance or policy in its place.   Still, many stakeholders have taken the position that stand-alone software products that provide decision support but that incorporate “competent human intervention” are exempt from FDA’s 510(k) premarket notification requirements.

However, the agency appears to be moving away from the “competent human intervention” exemption, and has recently required a number of manufacturers of software decision support tools to seek premarket clearance for these software programs.  In this environment, it is difficult to determine whether an agency policy shift is underway.  However, FDA’s recent treatment of these products and the lack of a definitive policy leaves both commercial manufacturers and healthcare institutions without definitive guidance as to the regulatory status of these software based decision support tools, specifically, whether such programs are exempt from 510(k) premarket notification and other regulatory requirements.  Until such time as FDA issues new policy guidance, uncertainty will remain as to how FDA intends to regulate decision support tools going forward, and the applicability of the agency’s historical policy position.