FDA has issued final guidance explaining how it intends to apply its drug-labeling authorities to certain software outputs disseminated by or on behalf of prescription-drug sponsors. The agency announced it October 20; a notice published in the Federal Register October 21 describes the guidance and how to comment.
What information the guidance covers
The notice describes software that produces content supplementing, explaining or otherwise textually related to a sponsor's prescription medicine. It also covers prescription drug-led, drug-device combination products assigned to FDA's Center for Drug Evaluation and Research or Center for Biologics Evaluation and Research as the lead center. End users can include patients, caregivers and healthcare practitioners.
FDA says it considers that output a form of prescription-drug labeling. The guidance addresses when content is treated as FDA-required labeling or promotional labeling, how prescribing information should describe software functions, and when and how companies should submit output for review.
According to FDA's announcement, apps connected to a medical device, such as an asthma inhaler, generally should be described in the medicine's prescribing information. Standalone symptom trackers, dose reminders and coaching tools should appear there if the company can show the app is essential for safe and effective use or can demonstrate a meaningful clinical benefit. In most cases, FDA says content displayed by a companion app will be treated as promotional material.
Final guidance, with legal limits
The notice finalizes a draft issued September 19, 2023. Changes include clearer treatment of standalone functions, a decision tree for labeling decisions and examples of prescribing-information language.
The final guidance represents FDA's current thinking. The notice expressly says it does not establish rights and is not binding on FDA or the public. An alternative approach is permitted if it meets applicable statutes and regulations. This is not an announcement that every companion app has received FDA approval.
Comments can be submitted at any time
The notice permits comments on the guidance at any time under docket FDA-2023-D-2482. It directs electronic submissions through Regulations.gov and provides paper-submission instructions for confidential material.
FDA warns that electronic comments and attachments will be posted unchanged. Anyone submitting confidential information should follow the notice's separate paper process rather than include it in an ordinary electronic comment. There is no new closing date in this notice.