OasisLMS

For more than a decade, the regulation of laboratory-developed tests (LDTs) has been at the center of efforts to reform the long-standing oversight framework, including through FDA guidance documents, proposed Congressional legislation, and the issuance of new regulatory policies. This session will provide an overview of the recent legal challenges that successfully vacated the FDA’s Final Rule aimed at LDT regulation, examine the current state of LDT oversight in light of these rulings, and explore potential pathways for regulatory evolution over the next few years.

This session offers 1.0 CME/CMLE credit.

Faculty/Authors

Physician Competencies: Systems-Based Practice (SBP), Medical Knowledge
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:

1. Review the Technical Considerations.
2. Review the Faculty Disclosures.
3. Click Go to Course to view an overview of the modules in this course.
4. Click Access to begin the course.
5. Submit the course Evaluation.
6. Enter the maximum number of credits offered and click Claim CME to register credit.

Faculty Disclosure

Technical Considerations

Release Date: 11/19/2025
Review Date:
Expiration Date: