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943-16 SS Update on FDA’s Role in Regulatory Oversight of LDTs

April 15, 2023 — 14, 2017

Location:


Available April 15, 2016 - April 14, 2023

Approved for 1.0 P.A.C.E. ®, Florida or CPH-Recertification Credit; CEUs accepted by all licensure states.

This program is available the day after the live program and is accessible 24 hours a day, 7 days a week!

REGISTER YOUR SITE NOW! $135 for ASCLS members and Training Coordinators, $150 for others includes; unlimited access to the archived webinar and CEUs for twelve months..
REGISTER AS AN INDIVIDUAL NOW! $25/person includes limited access and CEUs for one person.
Payment Options: Pay online using a credit card or by check payable to APHL with a registration form. Click here for a registration form.

Description
In 2010, the FDA announced that it would be proposing a regulatory scheme under which the FDA would begin to regulate laboratory developed tests (LDTs). In October of 2014, the FDA issued a draft guidance proposing such a framework. Following the issuance of the guidance the FDA held a public meeting and has actively met with stakeholders. The FDA also received over 300 comments on the guidance. The FDA has been working on finalizing the guidance based on the comments it received. At the same time, several stakeholders have introduced proposals that range from changing the regulatory scheme for all in vitro diagnostics to schemes that would give CMS the regulatory purview over laboratory developed tests. This webinar will discuss the FDA’s latest thoughts on LDT regulatory oversight and other pertinent proposals.

Objectives
At the conclusion of this program, the participant will be able to:

  • Discuss the FDA’s latest thoughts on LDT regulatory oversight and other pertinent proposals

Faculty
Katherine Serrano

Deputy Director of FDA’s Division of Chemistry and Toxicology Devices
Office of In Vitro Diagnostic Device Evaluation and Safety, FDA
Silver Spring, MD

Additional Information
Registration deadline: March 31, 2023

Problems Registering? Please email registrar@aphl.org or call 240.485.2727 between 8:00 am - 4:30 pm ET.

 Send check and registration form to APHL Registrar PO Box 79117, Baltimore, MD, 21279-0117. Be sure to include the number of the course on the check. If no registration form is received, your check will be deposited but you may not be registered for the course or get a confirmation notice. We do not accept purchase orders.

Cancellation Policy: We are unable to offer refunds for cancellations.

Click here for more information on CEU credit and more.

REGISTER YOUR SITE NOW!
REGISTER AS AN INDIVIDUAL NOW!

Click here for a complete list of available webinars and archived webinars.

Sessions
There are no additional sessions for this event.