The U.S. Food and Drug Administration (FDA) on October 20 issued final guidance on software that drug companies distribute for use with prescription medicines, from apps paired with an inhaler to standalone dose reminders and symptom trackers. The document, “Regulatory Considerations for Prescription Drug Use-Related Software,” treats what such software shows to patients and clinicians as a form of prescription drug labeling and sets out when it must appear in a drug’s prescribing information and what companies must submit to the agency.
The guidance finalizes a draft issued on September 19, 2023, under docket FDA-2023-D-2482, according to the FDA’s guidance page. It was issued jointly by the Center for Drug Evaluation and Research (CDER), the Center for Biologics Evaluation and Research (CBER), the Center for Devices and Radiological Health (CDRH), the Oncology Center of Excellence and offices within the Office of the Commissioner, and applies to prescription drugs and drug-led drug-device combination products for which CDER or CBER is the lead center. The agency classifies it as Level 1 guidance.
What the guidance says
The FDA’s announcement frames the document around three questions: when app content counts as FDA-required labeling and when it counts as promotional labeling; when an app should be mentioned in a drug’s prescribing information; and what companies should submit to the FDA when they distribute app content to users.
It divides companion software into two categories. Software connected to a medical device, the agency’s example being an app paired with an asthma inhaler, should generally be described in the drug’s prescribing information. Standalone software, such as symptom trackers, dose reminders and health coaching tools, should appear in the prescribing information only if the company shows that the app is essential for safe and effective use or demonstrates a meaningful clinical benefit. In most cases, the FDA said, content a standalone app shows users will be treated as promotional material, as with other drug advertising.
According to reporting by the Regulatory Affairs Professionals Society (RAPS), the final version adds a decision tree to walk sponsors through labeling determinations, provides example prescribing-information language for both categories, recommends a prescribing-information statement for device-connected software functions that do not demonstrate “meaningful improvement in a clinical outcome,” clarifies the treatment of standalone functions and replaces the draft’s term “digital health technologies” with “software with prescription drugs.” Sponsors do not need to resubmit end-user output for software updates that do not change previously submitted content, RAPS reported. The guidance covers AI-enabled software, according to an analysis by the law firm Orrick, which noted that the FDA’s core premise is that any content the software presents to a patient, caregiver or clinician is labeling.
“Mobile apps are playing a growing role in how patients manage their medications and health conditions,” said Capt. Chris Wheeler, director of CDER’s Division of Medical Policy Programs, in remarks reported by RAPS. CDER Director Michael Davis said the guidance “reflects FDA’s commitment to responsible, risk-proportionate oversight of digital health.” Jared Seehafer, the FDA’s deputy commissioner for technology, said in the agency’s release: “Companion apps are quickly moving beyond simple dose reminders toward tools that adapt to each patient.”
Why it matters
For drugmakers and the digital health developers they work with, the guidance settles a question that has been open since the 2023 draft: app output is labeling, and the bar for getting a standalone app into the prescribing information is evidence that it is safety-critical or clinically beneficial, not convenience. Orrick’s analysis lists the practical consequences: inventory every app, web tool and software function tied to a prescription product, including those built by vendors; classify each as device-connected or standalone and document the evidence; route app content through medical, legal and regulatory review; set up change control so new features and algorithm updates are assessed before release; and revisit contracts with app developers.
For patients and clinicians, the agency’s stated aim is accuracy. “This guidance helps ensure that the information these tools provide is accurate,” Wheeler said in the release. Davis said that by aligning the approach across drug and device centers, “we are giving developers a clear and consistent pathway.”
What to watch
RAPS reported that the FDA may issue further guidance on certain updates to end-user output. Orrick advised companies with marketed companion apps to begin assessments now, since the FDA expects to apply its current thinking going forward. Companies developing new products will need to decide during clinical planning whether to pursue software claims and what data those claims will require, the firm said.
The caveats
The press release gives only a high-level description; the full decision tree, definitions and submission details are in the guidance document itself. The summaries of what changed from the draft come from trade press and legal analysis rather than from the agency’s release, and the guidance does not address how the FDA will enforce the labeling framework against existing apps.
This article is for general information and does not replace advice from a qualified clinician. Corrections: email the editor using the address on the Contact page.
