ARUP Statement on FDA Final Rule to Regulate Laboratory-Developed Tests as Medical Devices

SALT LAKE CITY—A final FDA rule regulating laboratory-developed tests (LDTs) as medical devices does not address serious concerns raised by ARUP Laboratories and the clinical laboratory community, and the company’s stance on the rule has not changed, CEO Andy Theurer said today. ARUP believes the FDA does not have statutory authority over LDTs and maintains that the rule will limit access to essential testing services, stifle innovation, and increase healthcare costs.

The final rule differs from the FDA’s proposed rule published in October in that it supports enforcement discretion in some instances, such as for LDTs currently on the market and for those approved by the New York State Clinical Laboratory Evaluation Program (CLEP).

“ARUP is evaluating and reviewing the final rule, including any changes, internally and with our industry partners, to determine next steps,” Theurer said. “Our focus remains on supporting our patients and our clients to ensure they do not lose access to the essential services we provide.”

ARUP formed a task force in the fall of 2023 to prioritize planning in advance of the new regulations.

“ARUP is committed to maintaining our extensive test menu and advocating at the national level on behalf of the clinical laboratory community and the patients we serve,” said Jonathan Genzen, MD, PhD, chief medical officer and senior director of governmental affairs.

The rule will be phased in over the next four years. In the first year, by May 6, 2025, laboratories that offer LDTs will be required to file medical device reports with the FDA.

Year two adds requirements for registering and listing LDTs with the FDA. By year three, clinical laboratories would need to begin applying FDA quality system requirements (QSRs), and by year three and a half, clinical laboratories would be required to submit premarket approvals for high-risk LDTs. Current FDA user fees can be as high as $483,000 for each premarket authorization submission. The final stage, at year 4, adds premarket notification requirements for low- and moderate-risk LDTs.

In a November 28, 2023, public comment on the FDA’s proposed rule, ARUP urged the FDA to withdraw the proposal, citing negative impacts to patient care and innovation. (ARUP’s public comment is linked here.) ARUP believes the FDA used exaggerated estimates in the number of LDTs ordered and flawed data about their performance. LDTs address a vital need and have an excellent performance record in ARUP’s laboratories and in external proficiency testing.

ARUP also challenged the agency’s regulatory authority over laboratory-developed testing services. Congress gave the FDA authority to regulate medical devices, but if Congress had intended the FDA to regulate laboratory-developed testing services as medical devices, lawmakers would have included this concept in the text of the Medical Device Amendments of 1976 (MDA), and it did not.

As an alternative to FDA regulation of LDTs, ARUP has advocated for a collaborative process to update existing regulations that now govern clinical laboratories under the Centers for Medicare and Medicaid Services Clinical Laboratory Improvement Amendments. Genzen said a collaborative legislative approach would be a better option.

“We are disappointed that the FDA enacted the rule, denying many stakeholders the opportunity to collaborate on an oversight framework aligned with clinical laboratory expertise and resources in order to better protect patients and future innovation,” Genzen said.

He added that he and ARUP Chief Compliance Officer Jonathan Carr, JD, will host an educational webinar on the FDA rule. The date and time will be announced soon.

Additional ARUP Laboratories’ and industry partner resources are available here.

About ARUP Laboratories

Founded in 1984, ARUP Laboratories is a leading national reference laboratory and a nonprofit enterprise of the University of Utah and its Department of Pathology. ARUP offers more than 3,000 tests and test combinations, ranging from routine screening tests to esoteric molecular and genetic assays. ARUP serves clients in all 50 states, including many of the nation’s top university teaching hospitals and children’s hospitals, as well as multihospital groups, major commercial laboratories, group purchasing organizations, military and other government facilities, and major clinics. In addition, ARUP is a worldwide leader in innovative laboratory research and development, led by the efforts of the ARUP Institute for Research and Innovation in Diagnostics and Precision Medicine™. ARUP is ISO 15189 CAP accredited.

ARUP Media Contact

Bonnie Stray, bonnie.stray@aruplab.com, 801-583-2787 ext. 2823