{"id":7955,"date":"2025-01-20T13:54:30","date_gmt":"2025-01-20T13:54:30","guid":{"rendered":"https:\/\/els-solutions.com\/cms\/dev\/?p=7955"},"modified":"2025-01-20T13:56:41","modified_gmt":"2025-01-20T13:56:41","slug":"fda-issues-preliminary-guidance-for-medical-devices-with-artificial-intelligence-2","status":"publish","type":"post","link":"https:\/\/els-solutions.com\/en\/fda-issues-preliminary-guidance-for-medical-devices-with-artificial-intelligence-2\/","title":{"rendered":"FDA issues preliminary guidance for medical devices with Artificial Intelligence"},"content":{"rendered":"

The US Food and Drug Administration (FDA) has issued a draft guidance<\/a><\/strong> for Developers of Artificial Intelligence-Enabled Medical Devices.<\/p>\n

If finalized, this will be the first guidance to provide comprehensive recommendations for AI medical devices, offering their creators an accessible set of considerations that promote the safety and effectiveness of the devices.<\/p>\n

This guidance aligns with the FDA’s commitment<\/strong> in promoting safe<\/strong> and effective innovations<\/strong> in the sector, and it has also issued preliminary guidance<\/a><\/strong> on the use of AI in the development of drugs and biological products.<\/p>\n

 <\/p>\n

Artificial Intelligence and the medical device market<\/h3>\n

In the United States, the number of medical devices with artificial intelligence has increased significantly<\/a><\/strong> over the last decade.<\/p>\n

The FDA has already approved more than 1,000 devices based on AI or machine learning and has also seen a huge increase in new product submissions<\/strong>.<\/p>\n

In academia, studies<\/a><\/strong> are being carried out on the importance of analyzing the regulatory frameworks of the main regulatory bodies, focusing on the implementation of international standards and global safety protocols.<\/p>\n


\nRecommendations for Post-Market Monitoring and Risk Management<\/strong><\/h3>\n

A credibilidade da IA<\/strong> \u00e9 um dos principais focos da FDA devido aos problemas \u00e9ticos e aos desafios que a Intelig\u00eancia Artificial pode trazer \u00e0s empresas.<\/p>\n

O contexto de uso<\/strong> de um modelo de IA, ou seja, como ele \u00e9 aplicado para resolver quest\u00f5es espec\u00edficas, \u00e9 crucial para avaliar sua credibilidade.<\/p>\n

Desta forma, a FDA prop\u00f5e um quadro baseado em risco<\/strong> para validar modelos de IA e garantir confian\u00e7a nos seus resultados, alinhando-se com sua abordagem de an\u00e1lise de produtos farmac\u00eauticos<\/strong> e biol\u00f3gicos com IA<\/strong>.<\/p>\n

 <\/p>\n

Recomenda\u00e7\u00f5es para Monitoriza\u00e7\u00e3o P\u00f3s Mercado e Gest\u00e3o de Riscos<\/h3>\n

The draft guidance outlines recommendations on:<\/p>\n