Lab Test Ruling Could Apply to AI at FDA: Researchers

Public health researchers are warning about the broader impact to emerging technologies in a March ruling (see story) by a Texas federal judge that struck down FDA’s final rule establishing a regulatory framework for ensuring the safety and effectiveness of laboratory-developed tests (LDTs).

Writing in a 5/5 Stat online opinion piece, the Yale and Harvard academic researchers say the decision, which asserts that the FDA does not have responsibility for the authorization and oversight of LDTs, removes established guardrails for diagnostic safety and accuracy that protect patients, and sets a dangerous precedent for public health. They previously submitted an amicus brief supporting FDA’s position in the case.

The piece notes that medical professionals have expressed concern about the ruling, pointing to past incidents where poorly validated tests harmed patients. It points to a worrisome position where the judge embraced the plaintiffs’ assertion that FDA lacks regulatory authority over LDTs because such products constitute “services,” not “medical devices.”

The authors contend that FDA has taken issue with “how the industry was gaming LDT exemptions to develop tests that competed with FDA-approved products without having to comply with the agency’s standards for safety and effectiveness. The argument that lab tests are suddenly now ‘services’ is an intellectual sleight of hand at odds with how diagnostic devices have long been regulated by the FDA.”

The court’s stance may chill FDA’s ability to adapt regulatory frameworks for emerging technologies and public health needs, according to the authors. “For example, the FDA already faces significant challenges for regulating the more than 1,000 medical devices on the market that incorporate artificial intelligence,” they write. “A manufacturer could hypothetically contest future regulations by arguing that AI — like lab tests — constitutes a ‘service’ rather than a ‘device.’”

The authors state that the court’s decision “upends this paradigm for laboratory testing, sidelining the FDA and leaving patients and doctors on their own, without LDT oversight.” The government has not commented on whether it plans to appeal, which seems unlikely given that the Trump administration previously signaled an interest in repealing the LDT regulation, the authors add.