Artificial Intelligence and the Life Sciences Industry: FDA and FTC Regulatory Update

16 May 2023
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Key Takeaways:
  • The life sciences industry is embracing the use of artificial intelligence (“AI”) while the regulatory framework continues to evolve.
  • On May 10, 2023, FDA issued a discussion paper on the use of AI and machine learning (“ML”) in drug development. FDA also recently issued draft guidance to formalize its approach to regulating AI/ML medical devices. The agency proposed the use of predetermined change control plans (“PCCPs”) to address the dynamic nature of AI. Under the proposed framework, modifications to a medical device in accordance with a PCCP would be allowed after the initial FDA authorization (without the need for a subsequent filing).
  • The FTC is also paying close attention to the growing use of AI and has advised companies that the agency may pursue enforcement against those marketing AI products with false or unsubstantiated claims.