The history of state preemption and medical device regulation: lessons for artificial intelligence oversight

TL;DR

This paper explores how past medical device regulations can guide current AI oversight in healthcare to ensure safety and clarity.

Contribution

The paper proposes a preemption clause for AI in healthcare, inspired by historical regulatory reforms.

Findings

State regulations on AI-enabled medical devices risk creating fragmented and inconsistent oversight.

A preemption clause could provide regulatory clarity and reduce compliance burdens.

Modernizing federal oversight with FDA expertise could support responsible AI advancement.

Abstract

Rapid expansion of artificial intelligence (AI) in health care has outpaced the United States' fragmented regulatory structure, which currently relies on overlapping albeit incomplete federal oversight from multiple agencies. In the absence of clear federal product standards, some states have advanced broad and inconsistent regulatory schemes that often sweep AI-enabled medical devices into consumer-protection frameworks not designed for clinically used technologies. These state-level requirements risk recreating the fragmented medical device regulatory landscape that existed prior to 1976, where inconsistent rules increased compliance burdens and undermined patient safety. Congress responded with the 1976 Medical Device Amendments (MDA), granting FDA jurisdiction over medical devices and simultaneously adding a preemption provision prohibiting states from enacting or enforcing requirements “different from, or in addition to” federal requirements while still respecting states' rights to regulate use in medical practice. Drawing on historical parallels to the MDA and emerging state laws, this article proposes a preemption clause limited to health care-related AI that is coupled with a modernized, flexible federal product oversight framework—grounded in the FDA's technical expertise and informed by least-burdensome principles. Patients, physicians, and entrepreneurs would gain regulatory clarity, reduced compliance fragmentation, and a supportive regulatory environment for pragmatic, responsible technological advancement.