The final rule on laboratory developed tests (LDTs) released by the U.S. Food and Drug Administration (FDA) on May 6, 2024 outlines five “phase out” stages occurring over a 4-year period. Stage 1 includes the first set of requirements that high-complexity CLIA laboratories will be required to adhere to if they are offering LDTs. These requirements include 1) medical device reporting, 2) corrections and removals reporting, and 3) quality system requirements specific for handling compliant files.
As the deadline for meeting these requirements – May 6, 2025 – is now less than a year away, it is critically important for clinical laboratories to understand what these requirements are, and more importantly, how they can begin to prepare for them in compliance with the final rule.
In this session, the speakers will begin by providing an easy-to-understand outline of the requirements underlying stage 1.They will also share with attendees the specific FDA regulations that define these requirements for additional reference. Important definitions related
to adverse events and medical device reporting will be reviewed, emphasizing areas where specific policies are required under the law. The speakers will review example medical device reports so that attendees can better understand events where reporting to the FDA will be expected. Lastly, the session will conclude with a brief overview of what to anticipate in preparation for stage 2 of the final rule and beyond.
Faculty/Authors
Jonathan Genzen, MD, PhD, FASCP
Michelle Campbell, MLS(ASCP)cmMBcm,S
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: 09/06/2024
Review Date:
Expiration Date: 03/06/2025