Key Takeaways
- • The FDA has issued final guidance clarifying when software outputs used with prescription drug products and drug-device combination products, including companion applications, are considered FDA-required labeling or promotional labeling.
- • The final guidance follows a September 2023 draft guidance and a 2018 Federal Register notice seeking public comment on the topic.
- • FDA clarified its treatment of standalone software, added a labeling decision tree and illustrative examples, and recommends that labeling specify when associated software is not necessary for safe and effective use.
- • Drug sponsors offering or planning companion software, and digital health developers, should plan regulatory strategy early, particularly where software claims are supported by clinical evidence.
Summary
The U.S. Food and Drug Administration has released final guidance clarifying how its drug labeling requirements apply to certain software outputs used with prescription drug products and drug-device combination products, including companion applications, according to an Akin Gump client alert published October 28, 2026.
The guidance builds on a draft issued by the FDA in September 2023 and a 2018 Federal Register notice that sought public comment on the topic. It provides a more defined framework for determining when software outputs constitute FDA-required labeling or promotional labeling, and whether the software should be described in the drug's Prescribing Information (PI).
Among the changes from the draft, the FDA clarifies its treatment of standalone software, adds a labeling decision tree and illustrative examples, and recommends that labeling specify when associated software is not necessary for safe and effective use. These additions are intended to make the agency's approach easier to apply in practice.
According to the client alert, the final guidance underscores the importance of early regulatory planning for drug sponsors that offer or plan to offer companion software. It also applies to digital health developers, particularly where sponsors intend to support software-related claims with clinical evidence.
The guidance builds on a draft issued by the FDA in September 2023 and a 2018 Federal Register notice that sought public comment on the topic. It provides a more defined framework for determining when software outputs constitute FDA-required labeling or promotional labeling, and whether the software should be described in the drug's Prescribing Information (PI).
Among the changes from the draft, the FDA clarifies its treatment of standalone software, adds a labeling decision tree and illustrative examples, and recommends that labeling specify when associated software is not necessary for safe and effective use. These additions are intended to make the agency's approach easier to apply in practice.
According to the client alert, the final guidance underscores the importance of early regulatory planning for drug sponsors that offer or plan to offer companion software. It also applies to digital health developers, particularly where sponsors intend to support software-related claims with clinical evidence.
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