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ITLPLEAD2306 - CME/CMLE - The FDA’s Proposed Rule on Laboratory Developed Tests
Course Description

Faculty/Authors
Ali Brown, MD 
Kelly Swails, MLS(ASCP)

CME/CMLE Credit: 0.75
Estimated Completion Time: 0.75 hour
Format: Online Educational Activity

Method of Participation
To complete the activity and receive credit, the participant must complete the podcast activity. CME certificates will be provided on-line.

Physician Competencies: Practice-Based Learning and Improvement

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 0.75 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. Review the Educational Activity.
  6. Submit the course Evaluation.
  7. Enter the maximum number of credits offered and click Claim CME to register credit.

Faculty Disclosure

Technical Considerations

Release Date: 10/20/2023
Review Date:
Expiration Date: 10/20/2026 

Course Objectives
Following completion of this activity, you will be able to:
  • How tests that are not FDA approved but designed in-house to fulfill a clinical need fall into the category of laboratory developed tests
  • Examples of common LDTs used in academic medical centers + large community health systems
  • The current regulations re: performance standards for LDTs under CLIA
Summary
Availability: On-Demand
Credit Offered:
0.75 CME/CMLE Credit
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