A VALID Approach to Regulating LDTs?
Speaker:
Eric Q. Konnick, MD, MS, Associate Professor, Department of Laboratory Medicine and Pathology, University of Washington
Contact Hours:
1.0
Date:
March 19, 2025 - March 31, 2027
Description:
Changes to the regulatory paradigm of clinical diagnostic tests has been sought by the FDA for more than a decade. The Verifying Accurate Leading-edge IVCT Development (VALID) Act is legislation that has been under development for several years, with recent and rapid movement through the legislative process. This presentation highlights key concepts of the most recent version of legislation and next steps for laboratories, regulators, and legislators.
Learning Objectives:
- Describe the legislative process of VALID to date.
- List the 3 risk categories within VALID and the approval process for each classification.
- Identify next steps in the legislative and/or implementation process.