The Food and Drug Administration (FDA) on May 6, 2024 issued a final rule to amend its regulations to make explicit that in vitro diagnostic products (IVDs) are devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act) including when the manufacturer of the IVD is a laboratory.
In this session, the speaker will engage the audience in a discussion and address critical questions. Whether you are a lab stakeholder, involved in R&D, a pathologist, clinician, lab technician, informaticist, quality assurance specialist, or part of leadership and management, you will find this session beneficial. You will gain insights into the FDA's current thinking and be prepared to ask questions that impact your current and future roles in your lab or organization.
Faculty/Authors
Prithul Bom
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