Presentation (CTI)

OBJECTIVES: Timely regulatory clearance of AI-enabled medical devices is a critical factor in determining when patients can access innovative digital health technologies. Despite rapid growth—exceeding 1,300 FDA authorizations by 2025—little is known about whether specific regulatory policy interventions have accelerated this trend or how market entry patterns have evolved across clinical specialties.
METHODS: We conducted an interrupted time series (ITS) analysis of monthly FDA authorizations of AI/ML-enabled medical devices from January 2016 to December 2025 (N=120 months; 1,345 authorizations). Device records were obtained from the FDA AI/ML-Enabled Device List linked with the openFDA database. Two policy interventions were examined: the FDA AI/ML Action Plan (January 2021) and the PCCP Final Guidance (December 2024). Autocorrelation-adjusted segmented linear regression models estimated changes in authorization level and trend. Subgroup ITS was conducted for non-radiology devices; descriptive analyses characterized PCCP adoption and manufacturer experience trends.
RESULTS: Monthly authorizations increased from 4.8 (pre-2021) to 17.6 per month (post-2021), a 3.7-fold increase (R²=0.827). Following the 2021 Action Plan, the rate of increase accelerated significantly (+0.148 devices/month; p<0.001). The PCCP Guidance was associated with an immediate level increase of +6.1 authorizations (p=0.007), coinciding with a surge in PCCP adoption from 5.3% (2024) to 20.4% (2025), particularly in non-radiology specialties (Anesthesiology: 31.2%). Non-radiology devices showed parallel acceleration post-2021 (+0.052 devices/month; p=0.017). First-time manufacturers declined from 62.9% (pre-2021) to 32.3% (2025), indicating market consolidation.
CONCLUSIONS: FDA regulatory policy interventions, particularly the 2021 AI/ML Action Plan and 2024 PCCP guidance, were associated with significant acceleration in AI device authorizations across specialties. Clear regulatory frameworks appear to catalyze digital health innovation. Growing PCCP adoption and market consolidation have implications for health technology assessment and reimbursement decisions globally, including jurisdictions developing AI device frameworks such as the EU MDR and emerging Asian regulatory systems. Future research should examine post-authorization real-world adoption and health economic outcomes.