The FDA’s current approach to AI in healthcare highlights significant gaps in regulatory preparedness. Although the FDA has approved thousands of AI-enabled tools, it still lacks the resources, clear guidelines, and enforcement power necessary to address the rapid advancements and risks of AI effectively. The agency has issued frameworks and adopted some risk-based approaches, but these efforts fall short, leaving companies in limbo and patient safety at risk. AI in healthcare demands consistent oversight, yet the FDA’s “wait-and-watch” approach, often leading to delayed action, hinders industry progress and creates uncertainty for innovators. Addressing these issues requires urgent congressional support, funding, and global regulatory collaboration. At the Kulkarni Law Firm, we help guide companies through this complex regulatory landscape to ensure compliance and safety. For more insights, subscribe to our podcast or reach out today.

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