FDA regulation of clinical decision support software.

Abstract

INTRODUCTION As the dust clears from the Food and Drug Administration’s (FDA) release of its longanticipatedFinalGuidanceonMobileMedicalApplications inSeptember2013(MMA Final Guidance),1 the attention of industry and regulatory actors may turn to a significant health technology area explicitly excluded from the MMA Final Guidance— clinical decision support (CDS) software.TheFDAplans to release a separate guidance document onCDS software,2 but until then, manufacturers of CDS software remain in a gray area without clear marketing pathways. However, recent recommendations by the working group established under the Food andDrug Administration Safety and Innovation Act of 2012 (FDASIA) propose a risk-based regulatory framework that the FDAmust take into consideration in its CDS software guidance.3