Weighing the Impact of FDA Regulatory Uncertainty on Clinical Decision Support Development
Clinical decision support (“CDS”) software is not getting the regulatory clarity it needs and deserves. Although the United States Food & Drug Administration (“FDA”) made CDS software guidance an “A-list” priority in its 2015 regulatory agenda, the Agency has yet to define the portion of CDS software it intends to regulate and, for that portion it does regulate, the appropriate regulatory pathway to market.
Of course, developing a regulatory framework for CDS software is no easy task, as FDA must strike a delicate balance between ensuring patient safety and promoting innovation. However, until a regulatory approach is defined, CDS innovators will be left in the dark with regard to the expected costs and timelines for CDS development. Such uncertainty has already contributed to delays in CDS products reaching the market and, worse yet, the abandonment of CDS development projects altogether.
In fact, in a recent survey of CDS developers, nearly two thirds reported encountering delays due to regulatory uncertainty, and one third reported that regulatory uncertainty caused them to abandon development of a CDS product. Without clear regulatory guidance on which CDS products will be regulated and, for those that are, how such products will be regulated, valuable CDS tools, which can improve health outcomes, enhance the quality and consistency of care, and increase efficiency, will be kept out of the hands of clinicians and patients.