海角直播 Responds to FDA LDTs Rule
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 海角直播 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.海角直播 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.
海角直播 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.
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海角直播 is one of the largest professional societies dedicated to the life sciences and is composed of 36,000 scientists and health practitioners. 海角直播's mission is to promote and advance the microbial sciences.
海角直播 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, 海角直播 promotes a deeper understanding of the microbial sciences to all audiences.
海角直播 is one of the largest professional societies dedicated to the life sciences and is composed of 36,000 scientists and health practitioners. 海角直播's mission is to promote and advance the microbial sciences.
海角直播 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, 海角直播 promotes a deeper understanding of the microbial sciences to all audiences.
