Lexology March 8, 2023
In recent years, the digitalization of the healthcare industry has been accelerated to meet demands for smarter devices and robotics, wearable technology, AI-based data analysis, and enhanced platforms and simulations, among others. This digitization has driven an increased interest in incorporating artificial intelligence (AI) and machine learning (ML) technologies into medical devices.
Over the last decade, the US Food and Drug Administration (FDA) has reviewed and authorized a growing number of devices using its 510(k) clearance, de novo, and approved premarket (PMA) approval processes with AI/ML functionality across many different therapeutic categories—and anticipates this trend to continue. In addition, AI and ML technologies may be used to support the investigation, development, and/or production of medical devices and other FDA-regulated products....
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