FIELD NOTE
The screens in your companion app are now drug labeling. FDA left the device half of the problem untouched.
On October 20 the FDA finalized a guidance it first proposed on September 19, 2023, answering a question manufacturers have been asking since the agency opened a docket on it in 2018: what, legally, are the screens a patient sees in software that ships alongside a prescription drug. FDA says the document resolves “longstanding uncertainty” about when that content triggers submission requirements and when it belongs on a drug’s label.
They are labeling. The final guidance states that FDA “considers end-user output from prescription drug use-related software to be a type of prescription drug labeling,” meaning every prompt, reminder, chart and coaching message the software puts in front of a patient, caregiver or clinician. The Federal Register notice published the next day, at 91 FR 66561 under docket FDA-2023-D-2482, describes the document as applying FDA’s “drug labeling authorities to certain software outputs.”
From there the guidance sorts. Software that draws on a device or device constituent part, an app paired with a connected inhaler or injector, generally gets described in the prescribing information under How Supplied or Storage and Handling. Standalone software that runs on user-entered data, symptom trackers, dose reminders, and adherence coaching reach the PI only if they are essential to the safe and effective use of the drug, or if adequate, well-controlled studies show a meaningful improvement in a clinical outcome. Otherwise, the guidance says those functions “should not be described in the PI.”
Whatever fails that test is promotional labeling. It goes to FDA on Form FDA 2253 at the time of initial dissemination and is policed the way drug advertising is policed. FDA’s own announcement of the document says that in most cases, content a companion app displays to users will be treated as promotional material.
What the guidance declines to do is touch the other half of the product. “This guidance does not alter the statutory or regulatory framework for devices,” it says, and where a software function also meets the device definition it sends the reader to “applicable CDRH policies.” CDRH is a co-issuing center on the document. It arrived without a rule of its own.
The draft went further. In 2023, FDA proposed that a sponsor whose software required a CDRH marketing submission would not need to file the end-user output on Form 2253 at all; CDRH’s premarket review would cover the drug-related representations in the software, and CDRH would consult CDER or CBER, as Ropes & Gray read it at the time. The final carries no such carve-out. The 2253 obligation now reads flatly, at initial dissemination, and the device submission is a separate errand.
For anyone building a connected delivery system, that is one set of screens and two review tracks: a 510(k) or PMA supplement at CDRH for the software function, a promotional labeling submission at CDER for what the function displays, and no commitment anywhere in the document that the two reviews will be talking to each other about the same pixels. CDER’s director said the guidance reflects the agency “aligning our approach across drug and device centers.” The alignment is in the vocabulary. It is not in the filing.
The evidence bar is the other thing to price. “Adequate and well-controlled studies” showing “meaningful improvement in a clinical outcome” is a drug-grade standard, and the guidance applies it to a software feature. A dose reminder that plainly helps adherence but was never run through a controlled trial is, by default, an advertisement. Teams that budgeted software development against a device pathway and assumed the clinical case rode along with the drug now have a line item they did not have on October 19.
Arnold & Porter reports that FDA also published a nonbinding memorandum defending the approach against a First Amendment challenge, resting on the integrated-transaction reasoning of Kordel and Urbuteit. An agency that ships a speech defense alongside guidance tells you where it expects the argument to happen.
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