Exploring Regulatory Hurdles: How to Navigate FDA Approval for AI-Enabled Medical Devices

This article provides an overview of the FDA’s approval process for AI-enabled Software-as-a Medical-Device (SaMD). Under the current regulation regime, there are three pathways through which an SaMD may be approved: De Novo, Premarket Approval (PMA), and 510(k). A review of the SaMDs that have received approval shows that the vast majority – over 96% – have received approval via the 510(k) pathway. 

There are three non-exempt FDA approval pathways: De Novo; Premarket Approval; and 510(k)…. The vast majority of SaMDs received approval via the 510k pathway. Of the 692 AI/ML-enabled devices reviewed, 96.5% (668) were cleared through the 510(k) pathway, 3% (21) were cleared through the De Novo pathway, and only 0.4% (3) were cleared via the PMA pathway. Furthermore, many of these AI-enabled devices were considered substantially equivalent to non-AI enabled predecessors.

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