Version-to-Evidence Traceability in Prescription Digital Therapeutics: A Cross-Sectional Study of Audited Public Regulatory Records

BackgroundClinical evidence for a prescription digital therapeutic concerns a particular implementation, whereas product names can persist across software changes.This study examined whether public regulatory documents explicitly link identified therapeutic software releases to supporting clinical evidence. MethodsAn exploratory cross-sectional audit study examined prescription software therapeutics within nine Food and Drug Administration (FDA) product codes derived from a published inventory.All eligible records in the nine product-code queries were included without an authorization-date restriction.The primary outcome was an explicit association between a designated therapeutic software release and clinical evidence in an FDA-posted authorization packet.Product names, study codes, protocol revisions, and operating-system versions were excluded as release identifiers.Clinical-program identification, software-assurance statements, and narrative explanations of implementation continuity were recorded separately. ResultsSeventeen authorization packets comprising 245 pages represented 15 product families.Every family had identifiable clinical evidence and a statement concerning software documentation or testing.One family (1/15, 6.7%) and one packet (1/17, 5.9%) contained a qualifying release-level link.The later EndeavorRx (Akili Interactive Labs, Inc., Boston, Massachusetts, USA) packet identified v3.0 in both the subject-device and clinical-study tables.Release consistency was not assessable for the other 14 families from the audited packets.Several records nevertheless documented aliases, renaming, content comparisons, or browser-tomobile transitions.An illustrative trial-protocol check located a therapeutic revision outside the regulatory corpus, demonstrating the limits of packet-only ascertainment. ConclusionsIn this product-code-based sample, public FDA documents generally identified clinical programs but seldom identified the therapeutic release associated with that evidence.This finding concerns public reporting specificity and does not establish inadequate validation or regulatory noncompliance.A concise public association among release identifiers, clinical studies, and documented changes could improve the interpretability of digital-treatment evidence.