Diagnostics Reform Heats Back Up with Introduction of the Verifying Accurate Leading-edge IVCT Development Act of 2021

The Verifying Accurate Leading-edge IVCT Development Act of 2021 (the “VALID Act of 2021,” the “VALID Act” or the “Act”) was introduced in both the House and Senate on June 24, 2021 by U.S. Reps. Diana DeGette (D-CO) and Larry Bucshon (R-IN) and U.S. Sens. Michael Bennet (D-CO) and Richard Burr (R-NC).

The bipartisan Act seeks to modernize regulatory oversight of IVDs, including laboratory developed tests (LDTs), by creating a single, diagnostics-specific, regulatory framework under the authority of the Food and Drug Administration (FDA) aimed at promoting innovation and improving patient and public health. Introduction of this legislation coincides with the introduction of numerous bills and other initiatives to provide coverage and reimbursement for diagnostics or therapies that have obtained FDA marketing authorization.¹ The COVID-19 public health emergency confirmed the importance of IVDs, but also highlighted uncertainties as to the regulatory requirements applicable to clinical testing. The VALID Act would address these regulatory uncertainties, while developing a legal framework for diagnostics that is distinct from medical devices.

Source: https://www.jdsupra.com/legalnews/diagnostics-reform-heats-back-up-with-5991225/