NOV 11, 2015 09:00 AM PST

Keynote: FDA's Proposed Framework for Regulatory Oversight of Laboratory Developed Tests

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  • Deputy Director, Division of Chemistry and Toxicology Devices, Office of In Vitro Diagnostics and Radiological Health, Food and Drug Administration Center for Devices and Radiological Health
      Katherine Serrano is the Deputy Director of FDA's Division of Chemistry and Toxicology Devices in the Office of In Vitro Diagnostic Device Evaluation and Safety. Ms. Serrano received a Bachelor of Science degree in Biomedical Engineering and a Bachelor of Arts degree in Spanish from the University of Minnesota, Twin Cities. Before working at the Food and Drug Administration, Ms. Serrano has held positions as a regulatory affairs professional at Boston Scientific Corporation and has worked as a Biomedical Engineer at the United States National Institutes of Health supporting new programs focused on cutting edge technologies in the field of bioengineering.
      Ms. Serrano joined the FDA in 2008 as a Commissioner's fellow where she worked on various policy issues related to in vitro diagnostics. At FDA, Ms. Serrano has worked as a scientific reviewer, the Chief of the Diabetes Diagnostic Devices Branch and as the Deputy Director for the Division of Chemistry and Toxicology Devices.


    FDA has generally not enforced applicable regulatory requirements on a group of IVD tests called Laboratory Developed Tests.  This use of “enforcement discretion” has been under review by the Agency for many years, and particularly since the Agency hosted a 2010 public meeting on this topic. This presentation will provide a general overview of IVD regulation and a discussion of the current regulatory situation for laboratory developed tests.  The presentation will further discuss FDA’s draft policy guidance for enforcement of applicable regulatory requirements for Laboratory Developed Tests which was published in October of 2014, will provide an overview of the feedback that was received from Stakeholders on this document and will discuss next steps in the guidance finalization process.

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