With the release of the US FDA’s Final Rule claiming oversight authority over laboratory developed tests (LDTs), this Town Hall is built to help you understand and navigate this new regulatory landscape.
An expert panel will decode the new ruling and answer your questions, including:
What are the requirements in the final rule?
- What are the deadlines of upcoming requirements?
- What requirements apply to different types of tests and settings?
- What are FDA quality system requirements under the final rule?
- What could this mean for laboratories moving forward?
Faculty/Authors
Jonathan R. Genzen, MD, PhD, FASCP
Chief Medical Officer and Senior Director of Government Affairs
ARUP Laboratories Professor, University of Utah Department of Pathology
William G. Finn, MD, MASCP
Medical Director, Joint Venture Laboratories (JVHL), Allen Park, MI
Past President, ASCP
Michelle Campbell, MS, MLS(ASCP)CMMBCM, SCCM
Senior Developer, Department of Laboratory Medicine and Pathology
Mayo Clinic
Adjunct Assistant Professor, Division of Clinical Laboratory Science
University of North Carolina at Chapel Hill
Moderator: Christopher Tormey, MD, MASCP
Professor of Laboratory Medicine; Director, Transfusion Medicine Fellowship, Laboratory Medicine
Yale School of Medicine
CME/CMLE Credit: 1.0
Estimated Completion Time: 1 hour
Format: Online Webinar and Evaluation
Physician Competencies: Medical knowledge
Accreditation Statement: The American Society for Clinical Pathology (ASCP) is accredited by the Accreditation Council for Continuing Medical Education to provide continuing medical education (CME) for physicians. This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME).
Credit Designation Statement: The American Society for Clinical Pathology (ASCP) designates this journal-based CME activity for a maximum of 1 AMA PRA Category 1 Credit(s)™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
Instructions
To claim CME/CMLE credit for the exercise, do the following:
- Review the Technical Considerations.
- Click Go to Course to view an overview of the modules in this course.
- Click Access to begin the course.
- Review the Educational Activity.
- Submit the course Evaluation.
- Enter the maximum number of credits offered and click Claim CME/CMLE to register credit.
Faculty DisclosuresTechnical Considerations
Release Date: 5/21/2024
Review Date:
Expiration Date: 5/21/2027