Navigating regulatory and policy challenges for AI enabled combination devices

Abstract

Artificial Intelligence (AI) has made it possible for traditional Combination Devices (CDs) to innovate in the healthcare industry by combining the technology and healthcare sectors in recent years. Nonetheless, the difficulties, such as dependence on predicate devices, are highlighted in the US Food and Drug Administration's (FDA) 510(k) process, particularly for AI that is constantly evolving. Even though software and AI are included by the European Union's (EU) new Medical Device Regulations, it is still challenging to incorporate adaptive algorithms into conformance evaluations. It is underlined how urgently frameworks aware of AI concerns such as model deterioration and data biases are needed. Manufacturers' difficulties with regulations are clarified by case studies and insights from recalled equipment. Proposed are flexible policy frameworks that provide a balance between quick innovation and patient protections. In order to facilitate the safe, efficient, and egalitarian deployment of AI, recommendations are made to regulators and policymakers, promoting worldwide standards.

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