This morning, the Food and Drug Administration (FDA) released a much-anticipated final rule regulating most laboratory tests as medical devices, attempting to end decades of regulatory uncertainty about the agency's perceived authority over laboratory-developed tests. The final rule marks a significant, controversial expansion in the scope of FDA's regulatory oversight, notwithstanding the important changes made to the October 2023 proposal. In addition, FDA released notable policy documents governing FDA oversight of testing during a Public Health Emergency which will inform FDA's overall enforcement approach in the diagnostics field.
The final rule and these guidance documents will have profound implications for clinical laboratories, manufacturers of health-care-related software, lab chemicals and equipment, clinical research organizations, and for the entire precision medicine industry. Biotechnology companies relying on companion or complementary diagnostic testing for drug development and commercialization should pay special attention to this shift in FDA regulation.
Please join us for a discussion about how the final rule and these new policies could affect your business, including new risks and opportunities for precision medicine. For those who are unable to attend live, a recording will be available.
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