American Society for Microbiology Responds to FDA LDTs Rule

May 2, 2024

The Food and Drug Administration’s (FDA) final rule to regulate laboratory-developed tests (LDTs) raises a number of questions about the impact of these regulations on clinical and public health laboratories and the patients they serve. While FDA responded to a number of the concerns raised by ASM and its members, we remain concerned that the overall approach will stand in the way of innovation and limit patient access. In addition, the medical device pathway is ill-suited for regulation of LDTs. 

ASM put out a call for information to approximately 740 clinical microbiology laboratory directors in response to the FDA's proposed rule. The data they shared, along with the individual responses from members of the clinical microbiology community, were instrumental in the modifications included in the final rule.
ASM will continue to seek a viable solution to the regulation of LDTs to ensure that there is a framework that accounts for the needs of rapid infectious disease testing and protects patient access to appropriate, accurate and timely diagnostics when they matter most.

The American Society for Microbiology is one of the largest professional societies dedicated to the life sciences and is composed of 36,000 scientists and health practitioners. ASM's mission is to promote and advance the microbial sciences.

ASM advances the microbial sciences through conferences, publications, certifications, educational opportunities and advocacy efforts. It enhances laboratory capacity around the globe through training and resources. It provides a network for scientists in academia, industry and clinical settings. Additionally, ASM promotes a deeper understanding of the microbial sciences to diverse audiences.

Author: ASM Advocacy

ASM Advocacy
ASM Advocacy is making it easy and providing opportunities for members to advocate for evidence-based scientific policy.