NOV 11, 2015 09:00 AM PST

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

Speakers
  • 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
    MAY 22, 2018 08:00 AM PDT
    C.E. CREDITS
    MAY 22, 2018 08:00 AM PDT
    DATE: May 22, 2018TIME: 08:00AM PDT The nuclear receptors pregnane X receptor (PXR) and constitutive androstane receptor (CAR) are closely related transcription factors that...
    MAY 03, 2018 11:00 AM PDT
    MAY 03, 2018 11:00 AM PDT
    DATE: May 3, 2018TIME: 11:00AM PDT, 2:00PM EDTWhile stress is one of the leading causes of neuropsychiatric disorders, the molecular underpinnings of how stress induces alterations in b...
    MAY 24, 2018 09:30 AM PDT
    C.E. CREDITS
    MAY 24, 2018 09:30 AM PDT
    DATE: May 24, 2018 TIME: 9:30PM PDT The current gold standard in in vitro pre-clinical cancer treatment screening remain cell lines,...
    JUN 26, 2018 06:00 AM PDT
    C.E. CREDITS
    JUN 26, 2018 06:00 AM PDT
    Date: June 26, 2018Time: 6:00 a.m. PDT, 9:00 a.m. EDT, 1500 CEST Today’s hematology analyzers employ various methods for enumerating platelets. These methods include: e...
    JUN 20, 2018 10:00 AM EDT
    C.E. CREDITS
    JUN 20, 2018 10:00 AM EDT
    DATE: June 20, 2018TIME: 07:00AM PDT, 10:00AM EDTIntroducing GE’s New Lyo-StableTM service. Sepsis is one of the top challenges facing hospitals in terms of clinical outcomes...
    APR 27, 2018 10:00 AM PDT
    C.E. CREDITS
    APR 27, 2018 10:00 AM PDT
    DATE: April 27, 2018TIME: 10:00am PST, 1:00pm ESTGlioblastoma (GBM) and Medulloblastoma (MB) are the most common adult and paediatric brain tumours, both of which can have devastating c...
    Loading Comments...