FDA Clarifies Labeling Expectations for Prescription Drug Use-Related Software
Summary
• : Software Functions that rely on data directly transferred from the device constituent part of a sponsor’s combination product. FDA makes clear that the Guidance is intended to align with, not override, the digital health framework being developed for device-related software by CDRH. This expansion represents a significant step in the formation of FDA’s regulatory scheme for digital health products, which is consistently evolving to keep up with the rapid pace of innovation. As part of the development process for Prescription Drug Use-Related Software products – for example, an app that collects patient data from an orally ingested sensor device taken with a certain drug or an app that allows patients to track symptoms in a standardized manner over time – sponsors should analyze the three factors[9] to determine whether the software output qualifies as “FDA-required labeling” or “promotional labeling.” If the output qualifies as FDA-required labeling, sponsors should take care to include all relevant risk/benefit information, including adequate and well-controlled studies, in the drug’s FDA marketing application or supplement. If the output qualifies as promotional labeling, sponsors should ensure that the information is not presented in a false or misleading manner, and should be prepared to submit an FDA Form 2253 at the time the software capability is disseminated.
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