The FDA’s regulatory approach for medical devices has evolved, particularly with the introduction of the Apple Watch in 2018, which was cleared for detecting irregular heart rhythms. This marked a shift towards a “firm-based” regulatory approach, focusing on the quality systems and processes of the manufacturing firm rather than the mechanics of individual products. This method emphasises the importance of a company’s quality management system to ensure consistent production and control, enhancing the safety and effectiveness of medical devices.

This approach is particularly relevant for regulating AI medical devices, which are designed to analyse vast amounts of data to generate clinical insights. The Verifying Accurate Leading-edge IVCT Development Act (VALID Act) aims to codify this firm-based approach, allowing the FDA to oversee the methods used to develop and validate AI technologies. This is crucial as AI models, like ChatGPT, evolve rapidly and can manage patient interactions. However, the complexity of these models poses challenges for traditional regulatory methods, necessitating new legislative frameworks to ensure effective oversight.

Source: JAMA Network