The U.S. Food and Drug Administration issued a draft guidance for industry entitled, Regulatory Considerations for Prescription Drug-Use-Related Software. In response to comments received from FDA’s November 2018 proposed framework “Prescription Drug-Use-Related Software,” the agency is issuing the draft guidance to provide clarity to drug sponsors about how FDA will apply its drug labeling authorities to end-user output of prescription drug-use-related software, how FDA-required labeling will describe certain prescription drug-use-related software, and when and how to submit end-user output to FDA.
Digital health technologies used with prescription drugs can potentially offer new ways to help treat patients. Software, including those designed for mobile apps are used for health-related purposes, such as assisting patients with tracking their own drug ingestion, allowing health care practitioners to monitor patients taking a prescription drug, or providing information on how to use a drug. Digital health technologies may provide insight to patients, caregivers, and health care providers (collectively known as “end-users”) about a patient’s drug use. When drug sponsors develop digital health technologies, like prescription drug-use-related software for use with one or more of their drugs, FDA will apply its authorities according to an evidence-driven, risk-based framework consistent with existing drug labeling authorities.