Timing of Manufacturer Announcements After Regulatory Authorization of Prescription Digital Therapeutics in the United States: A Retrospective Observational Study

BackgroundPrescription digital therapeutics are prescription-only software interventions intended to prevent, manage, or treat disease.Regulatory decisions and company announcements are distinct events.This study measured their interval in an identified, potentially incomplete cohort and examined located examples of public disclosure preceding company announcements. MethodsA retrospective document study used purposive (targeted), nonprobability sampling from a prior candidate list, targeted web searches, and regulatory records to identify prescription therapeutic software delivered through general-purpose mobile, tablet, or web platforms with initial United States Food and Drug Administration (FDA) authorization between January 1, 2017 and October 6, 2026.Hardware-dependent, diagnostic-only, over-the-counter, and unauthorized products were excluded.FDA decision dates were matched to the earliest dated manufacturer-issued authorization announcement located.Calendar-day intervals were summarized using medians, interquartile ranges, means, counts, and percentages.Other dated disclosures were examined separately; the first public posting of FDA documents was not reconstructed. ResultsThe identified cohort comprised 15 product families: six De Novo authorizations and nine 510(k) clearances.The median interval was three days (interquartile range, 1.5-6.5;range, 0-180), and the mean was 19.6 days.Three announcements (20.0%) occurred on the decision date, 12 (80.0%)within seven days, and 13 (86.7%)within 30 days.The two longest intervals were 180 and 67 days.Located public-source examples bearing earlier publication dates mentioned authorization before company announcements for four products; historical page versions were not independently reconstructed. ConclusionsIn this identified cohort, most located company announcements followed authorization within one week, with a small number of substantially longer intervals.Regulatory decision dates, manufacturer announcement dates, and evidence of earlier public disclosure should be reported separately.These descriptive findings do not establish the timing of first public availability or explain companies' communication decisions.