Advocacy - Lab Advocate
In June, the Policy & External Affairs Core Committee (PEACC) met with legislators and staff from key congressional offices regarding the FDA's final rule on laboratory developed tests (LDTs). The rule, which establishes unilateral regulatory oversight by the Food and Drug Administration (FDA), on top of existing Clinical Laboratory Improvement Amendments (CLIA) regulations, concerns ADLM and many others within the laboratory community. The association believes this additional layer of regulation is redundant and will impose significant operational and financial burdens on laboratories, stifling innovation and delaying the availability of critical diagnostic tests. ADLM is urging Congress to repeal the FDA rule and to address any concerns with LDT oversight within the context of CLIA.
In addition to seeking to revoke the rule, the association is educating its members and the broader laboratory community on the implications of the LDT regulations and how to comply with them. On June 3rd, ADLM hosted a webinar, “The U.S. Food and Drug Administration’s rule on laboratory developed tests — What it means for you” featuring regulatory and laboratory experts Dr. Steve Master and Dr. Jonathan Genzen, who provided crucial insights into how this new regulatory landscape will impact laboratories.
A follow-up webinar, “Complying with the FDA’s Rule on LDTs – What you need to Do and When” will take place on September 25th and build off our previous webinar, focusing on the specific regulatory changes relevant to operational planning, while offering practical guidance on how to meet the new regulatory requirements. The program will spotlight stages 1 & 2 of the regulation, such as issues pertaining to medical device reporting, registration, and labeling requirements, among others, while also addressing elements of stage 3 involving quality system requirements and design controls.