On May 6, 2024, the FDA officially released its final rule
on oversight of laboratory developed tests (LDTs), describing the phaseout of its general enforcement discretion approach for LDTs. The release of this final rule has raised many questions and concerns, specifically regarding how clinical laboratories may be impacted by the final rule, what the specific requirements of the rule are, and how laboratories should best prepare to comply with these requirements
in advance of the respective deadlines for compliance. In this “Meet the Experts” session, our panelists will moderate an interactive Q&A discussion involving attendees, laboratory leaders, and regulatory colleagues to walk through some of the more challenging aspects of the final rule. This session will highlight key issues, including a brief outline of the five stages of requirements, potential strategies to comply with the final rule, and recent updates on litigation and potential future legislation. Please join us for this timely, open, and engaging discussion on an issue that impacts all clinical laboratories that perform LDTs.
Faculty/Authors
Jonathan Genzen, MD, PhD, FASCP
Michelle Campbell, MLS(ASCP)cmMBcm,SCcm
Steven Kroft, MD, MASCP
Karen Kaul, MD, PhD, FASCP
William Finn, MD, MASCP
Physician Competencies: Patient Care, Medical Knowledge, Professionalism, Interpersonal Skills Communication
CME/CMLE Credit: 1.0
Estimated Completion Time: 1 hour
Format: Online Educational Activity
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.
- Review the Faculty Disclosures.
- Click Go to Course to view an overview of the modules in this course.
- Click Access to begin the course.
- Submit the course Evaluation.
- Enter the maximum number of credits offered and click Claim CME to register credit.
Faculty Disclosure
Technical Considerations
Release Date: 09/05/2024
Review Date:
Expiration Date: 03/06/2025