David Peloquin Discusses AI Regulatory Challenges Posed to Food and Drug Administration in Bloomberg Law

In The News
June 21, 2023

In a Bloomberg Law article, health care partner David Peloquin discussed the regulatory challenges posed to the U.S. Food and Drug Administration (“FDA”) by artificial intelligence large language models.

The FDA has the authority to regulate the use of large language models if they are used in products subject to FDA jurisdiction, such as medical devices.

David explains that existing regulatory principles in software and the medical device framework could be applied to AI models such as ChatGPT.

David notes that a key question with respect to FDA jurisdiction is what is the intended use and the extent to which the product has been validated.