Navigating FDA Regulatory and Litigation Risks With Al-Enabled Medical Devices and Non-Device Software: A Landscape Analysis for Medical Product Counsel

Product liability and mass torts counsel Jim Frederick, government and regulatory partner Barrett Tenbarge and health care associate Caroline Herion discuss the implications of artificial intelligence (AI) use in medical devices in an article for Defense Research Institute (DRI)’s For the Defense magazine. Government and regulatory partner Peter Blenkinsop and associate Simonne Brousseau also contributed to the article.

The co-authors provide an overview of the key litigation and liability considerations that new AI-enabled products face as the regulatory landscape continues to evolve. They note that regulatory submissions for AI-enabled medical devices have increased dramatically over the past five years, highlighting recommendations from the U.S. Food and Drug Administration to navigate this shift.

The authors also share that courts have started to grapple with how to apply the existing product liability legal framework in the U.S. to products incorporating AI and that general counsel should focus on proactive policies and be vigilant of data governance practices.