Advocacy - Lab Advocate
On August 28, 2024, ADLM submitted a letter to Acting Food and Drug Administration (FDA) Director Tarver, seeking urgent clarification on the May 2024 final rule regulating laboratory-developed tests (LDTs). The association compiled a list of critical questions surrounding key aspects of the rule, including what specific modifications to FDA-approved tests would trigger the need for premarket review. ADLM noted that many laboratories modify or automate tests to meet specific patient needs, but it remains unclear whether these changes would require additional FDA approval, leading to operational uncertainty.
ADLM also raised concerns about the FDA’s capacity to manage the volume of LDT submissions, particularly for complex tests involving mass spectrometry, genomics, and other advanced technologies. The association asked whether the FDA had the internal expertise to evaluate such tests and how it planned to address rare disorder testing, where traditional approval pathways may not be feasible due to limited specimen availability.
In terms of compliance, ADLM requested guidance on how post-market enforcement would be conducted, especially concerning reporting quality control failures as formal complaints—a process currently handled by CMS under CLIA. Additionally, the association sought clarification on whether LDT compliance would be enforced through inspections or other regulatory measures.
The association urged the FDA to provide clear and timely guidance on these issues, especially as labs prepare for the May 2026 compliance deadline. Without further clarification, ADLM warned that many labs may be forced to discontinue LDT services, which could have a devastating impact on patient care, particularly for those in rural and underserved regions.
To help laboratories navigate these complex issues, ADLM held a webinar on September 25, 2024, which provided practical guidance on how labs should address regulatory changes, focusing on medical device reporting, registration, and quality system requirements. For those unable to attend, the webinar can be accessed here to stay informed about how to meet these new requirements.
ADLM will continue to advocate vigorously on behalf of its members, working to ensure that regulatory frameworks for laboratory-developed tests are both practical and supportive of the high-quality diagnostic services provided by clinical laboratories across the country.