NOV 11, 2015 9:00 AM PST

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

Speaker
  • 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
    Biography
      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.

    Abstract

    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.


    Show Resources
    You May Also Like
    SEP 10, 2020 9:00 AM PDT
    C.E. CREDITS
    SEP 10, 2020 9:00 AM PDT
    Date: September 10, 2020 Time: 9:00am (PDT), 12:00pm (EDT) Osmolality testing is relevant throughout the entire bioprocessing workflow. As customers look to refine mAb and gene therapy workf...
    NOV 18, 2020 8:00 AM PST
    C.E. CREDITS
    NOV 18, 2020 8:00 AM PST
    DATE: November 18, 2020 TIME: 08:00am PDT We develop and implement technologies to solve some of the major bottlenecks in biomedical research. In particular, we establish new imaging approac...
    SEP 03, 2020 9:00 AM PDT
    C.E. CREDITS
    SEP 03, 2020 9:00 AM PDT
    DATE: September 3, 2020 TIME: 09:00am PT, 12:00pm ET xxx Learning Objectives: xxx Webinars will be available for unlimited on-demand viewing after live event. LabRoots is approved as a provi...
    C.E. CREDITS
    This drug development program is designed to create a family of broad-spectrum, pan-coronaviral drugs that respectively inhibit multiple key enzymes required for viral replication. By target...
    JUN 17, 2020 1:30 PM PDT
    C.E. CREDITS
    JUN 17, 2020 1:30 PM PDT
    Understanding the complex interplay between a pathogen and the host response is important to developing effective vaccines and therapeutics. The nCounter® Analysis System and GeoMx®...
    NOV 16, 2020 8:00 AM PST
    C.E. CREDITS
    NOV 16, 2020 8:00 AM PST
    Date: November 16, 2020 Time: 8:00am (PST), 11:00am (EST) CRISPR screening has become the prime discovery tool in modern biomedical research and drug discovery. At the same time, most screen...
    Loading Comments...
    Show Resources
    Attendees
    • See more