Major Regulatory Reform Legislation for In Vitro Diagnostics, Laboratory-Developed Tests Is Introduced
March 19, 2020 at 12:30 PM EST
Bipartisan legislation introduced in Congress March 5 would create a new risk-based approach to the FDA’s regulation of in vitro clinical tests (IVCTs), including in vitro diagnostics and laboratory-developed tests.
The 245-page Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2020 (H.R. 6102, S. 3404) would establish a system through which the FDA’s regulatory... Read More
