LDT UPDATE W/STACI KEARNEY (ELEVATION STRATEGIC CONSULTING)
Beyond the Scope
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Navigating FDA Regulations for Diagnostic Testing
This chapter explores the intricacies of FDA regulations for diagnostic testing, emphasizing the challenges providers face in accessing and interpreting information about breast molecular tests. It highlights the necessity for clearer FDA guidance on information disclosure and compliance timelines, underscoring the critical nature of understanding the regulatory landscape for medical device standards.
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