Clinical Diagnostics & Resarch Virtual Event Speaker Highlight: Katie Serrano
Our Clinical Diagnostics & Research Virtual Event is inching closer and we’re going to highlight one of our keynote speakers! If you haven’t done so already, head on over to the Clinical Diagnostics & Research Virtual Event page and sign up/register to save yourself a spot.
One of our main keynote speakers at the event will be Katherine (Katie) Serrano who is the Deputy Director of the Division of Chemistry and Toxicology Devices in the Office of In Vitro Diagnostics and Radiological Health at the Food and Drug Adminstration Center for Devices and Radiological Health. Katie will be presenting her keynote titled: FDA’s Proposed Framework for Regulatory Oversight of Laboratory Developed Tests where she will discuss the FDA possibly enforcing applicable regulatory requirements on a group of IVD tests called Laboratory Developed Tests.
This presentation is set to provide a general overview of IVD regulation and open up a discussion of the current regulatory situation for laboratory developed tests. This use of “enforcement discretion” has generally been under review by the Agency for many years and more so after the Agency hosted a 2010 public meeting on the topic. Aside from the general overview and discussion for the regulatory situation for the laboratory developed tests, the presentation will further discuss the FDA’s draft policy guidance for enforcement of applicable regulatory requirements for Laboratory Developed Tests which was published in October of last year (2014). It will provide an overview of the feedback that was received from stakeholders on the document and will discuss next steps in the guidance finalization process.
For those of you who are interested in seeing Katie speak, you’ll be able to catch her on Wednesday November 11 at 9:00am Pacific time. Be sure to check out other speakers that are speaking at the event as well.