Regulatory Considerations for Prescription Drug Use-Related Software

This document is a guide detailing the FDA's draft guidance on Regulatory Considerations for Prescription Drug Use-Related Software (PDURS) released in September 2023. It outlines how the FDA intends to apply its drug-labeling authority to software outputs associated with prescription drugs and drug-device combination products. The draft guidance introduces a new regulatory framework that clarifies the intersection of digital health technologies and pharmaceutical products. It defines PDURS, emphasizes the regulatory oversight from the FDA's various centers, and discusses the scope of PDURS, which is primarily intended for pharmaceutical manufacturers. The document also categorizes PDURS outputs as either promotional labeling or FDA-required labeling, explaining the criteria for each category. Additionally, it highlights the implications for drug sponsors regarding clinical evidence and regulatory submissions, particularly for software that provides meaningful clinical benefits. The guidance aims to facilitate the integration of digital health technologies within drug labeling and promotional materials.