Presentation (CTI)

OBJECTIVES: Software as a medical device (SaMD), is commonly studied in health economic and outcomes research, also referred to as medical device software (MDSW) in Europe. SaMD is required to undergo regulatory approval, and guidelines have been published by the Food and Drug Administration (FDA), Health Canada (HC), and the European Commission (EC). We have investigated these guidelines to observe the different classifications and their pathways to approval, as well as examples of SaMD.
METHODS: We conducted a scoping review encompassing published guidelines by the FDA, HC, and EC, and grey literature and summarized our findings.
RESULTS: Regulatory bodies’ definitions of SaMD require an intention for medical purposes, while their specific classification and subsequent regulatory pathways depend on the severity of the medical conditions and the significance of the information provided by the device. Higher risk classes (FDA: Class III and occasionally II; HC: Class III, IV, and occasionally II; EC: Class IIb, III, and occasionally IIa) require clinical data for approval to demonstrate safety and effectiveness of the SaMD. The FDA, HC, and EC have evaluated a variety of SaMD including AliveCor KardioMobile, an electrocardiogram monitoring app which detects atrial fibrillation. Since the inception of their regulatory classification HC has approved over 1,000 SaMDs. Meanwhile, in 2023, the FDA had approved 135, increasing from an average of 59 over the last five years. The most common SaMD therapeutic areas approved by the FDA are radiology (64.3%), cardiovascular (12.9%), and general hospital (4.4%).
CONCLUSIONS: While North America and Europe share similar definitions and classifications of SaMD, differences in timelines and frameworks highlight the need to navigate these landscapes carefully. Ongoing collaboration between regulators and industry stakeholders is essential to adapt regulations for recognition of evidence and documentation, ensuring safety and innovation in healthcare delivery.