For more than four years, members of both houses of Congress have solicited input from a variety of stakeholders to improve the Food and Drug Administration (FDA) oversight of Laboratory-Developed Tests (LDTs). The result is the Verifying Accurate Leading-edge IVCT Development (VALID) Act, a bi-partisan and bi-cameral bill designed to empower the FDA to regulate diagnostic tests. While the bill has not been passed yet, it is likely that it will move forward in some form and eventually become law.
This guide will help your IVD product team understand the provisions and implications of the VALID Act and how it applies to product development and risk management for medical devices.
Download this eBook to learn more about:
- Provisions of the current version of the VALID Act
- The debate about whether or not it should be mandated
- Implications of passing the VALID Act