In a move to advance digital health technologies, the US Food and Drug Administration (FDA) has issued a Federal Register notice, “Prescription Drug-Use-Related Software” to seek early input from the public on the agency’s proposed framework for prescription drug-use-related software. Prescription drug-use-related software refers to software disseminated by or on behalf of a sponsor that accompanies one or more of the sponsor’s prescription drugs or biologics.

The proposed framework is designed to take a risk-based approach to prescription-drug-use-related software. Under this approach, the FDA anticipates that in most cases, such software would not require review by the FDA prior to dissemination. Generally, the FDA says the output of such software products—screen displays or audio messages—would be regulated as promotional drug labeling and would be subject to existing post-marketing requirements for such labeling. In other cases, such as when a sponsor seeks to demonstrate that the software has an effect on a clinically meaningful outcome and seeks to include information about the software in the FDA-required drug labeling, prior FDA approval would be required, according to information from the FDA.

“By providing more clarity around how these prescription-drug-use-related software products will be regulated—and by defining the most efficient pathway for these digital technologies while also ensuring that these tools meet the FDA’s current requirements—the agency hopes to promote development of these innovations,” the FDA said in a November 19, 2018 agency statement. “The FDA’s proposed approach, which treats certain software output as prescription drug labeling, does not alter the regulatory framework for what meets the definition of being a medical device. The aim is to pursue a risk-based and least burdensome approach to these products to promote beneficial innovation that can promote healthcare goals and advance patient health and safety.”

With this notice of action, the agency intends to provide a clear and predictable pathway for stakeholders on the FDA’s approach to the regulation of software developed by, or on behalf of, drug sponsors for use in conjunction with one or more of their prescription drug products.

The FDA says it encourages stakeholders to provide comments to the docket about prescription drug-use-related software. The docket will be open until January 22, 2019.

Source: FDA