FDA releases guidance on labeling of drug use-related software outputs
The US Food and Drug Administration (FDA) has released draft guidance with considerations on how to include software outputs of drug use-related software in prescription labeling.In the draft guidance, FDA defines prescription drug use-related software as including software disseminated by the drug sponsor or an entity acting on behalf of a sponsor that creates an end-user output that “supplements, explains, or is otherwise textually related to one or more of the sponsor’s drug products.” The agency said it considers end-user output from drug-related software as a type of prescription drug labeling.
FDA initially opened a docket in November 2018 to seek public comments on a proposed framework for regulating software applications related to prescription drug products.
Comments from stakeholders -- which included pharmaceutical companies, trade associations, digital health companies, and coalitions -- were generally supportive, but called on FDA to align the prescription drug-use-related software framework with regulatory initiatives in the Center for Drug Evaluation and Research (CDER), Center for Biologics Evaluation and Research (CBER) and the Center for Devices and Radiological Health (CDRH) (RELATED: Industry Seeks Cross-Center Alignment in FDA Proposal on Prescription Drug Software, Regulatory Focus 02 April 2019).
The draft guidance, which was released on 18 September 2023, was created in response to public comments about the framework, according to FDA (RELATED: FDA Proposes New Framework on Prescription Drug-Related Software, Regulatory Focus 19 November 2019).
In the draft guidance, FDA said the recommendations are intended to align with initiatives “across all product centers,” including CDRH digital health initiatives, and is not an alteration of the current regulatory framework. “Rather, it focuses on the application of drug labeling authorities to the end-user output of prescription drug use-related software, regardless of whether such software is regulated as a device under the Federal Food, Drug, and Cosmetic Act (FD&C Act),” the agency wrote.
The agency said its focus for now is on oversight of functions for drug-related software where there is a “risk to a patient's safety if the device were not to function as intended.” While there may be instances where end-user output of software functions is considered a device, FDA believes “a significant proportion” of output will be direct information to a patient about use of a prescription drug.
The draft guidance includes specific recommendations about what to include in the prescribing information for drug use-related software, including a summary of the “essential scientific information needed for the safe and effective use of the drug product” and information on the drug and device constituent part for combination products. The guidance notes that a description of device-connected software functions and end-user output of the device-connective software functions should typically be included. Additionally, the information “should be consistent with the general approach used” for prescribing information, FDA advised.
Drug sponsors with products that have drug use-related software that leads to a clinically meaningful benefit can propose including that data on the prescribing information, while sponsors who have not submitted evidence of clinically meaningful benefit from drug use-related software, such as with combination products, can include a description of the relationship between the software and the device. In the latter case, “information beyond describing the device constituent part and associated software function(s) or statements suggesting a clinical benefit should not be included,” the agency said.
End-user output data and updates to end-user output functionality in the software that are considered promotional labeling should be submitted at the time of dissemination, but security updates and other software updates that do not alter end-user output are not required.
Guidance
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