AABB Publishes Analysis of Bill Establishing Regulatory Framework for LDTs

AABB has prepared an analysis of the Verifying Accurate Leading-edge IVCT Development (VALID) Act, that is part of Senate bill S. 4348, which would establish a new framework for the Food and Drug Administration to regulate in vitro clinical tests (IVCTs). In vitro diagnostics (IVDs) and laboratory developed tests (LDTs) would be regulated as IVCTs.

The bill would create a variety of requirements for IVCTs, such as a premarket review approval program, a technology certification program for developers of certain IVCTs, risk-based classifications, expedited development and priority review for breakthrough tests, registration requirements, labeling requirements, an appeals process, and postmarket surveillance requirements. The legislation also creates a third-party reviewer program. FDA would be charged with promulgating regulations and developing guidance that interprets, implements and operationalizes the new regulatory framework.

The VALID Act is currently included in the Senate’s version of the FDA user fee program reauthorization package known as the FDA Safety and Landmark Advancements Act (FDASLA) of 2022 (S. 4348). The Senate Committee on Health, Education, Labor and Pensions (HELP) is having a hearing on the bill on Tuesday, June 14.

AABB’s analysis outlines the legislation’s major provisions along with considerations for the blood and biotherapies community. AABB will continue monitoring the status of the bill and will work with laboratory and medical groups, regulators and other policymakers to advocate for related policies to be minimally burdensome and to reflect the interests of AABB’s members.

AABB members may contact advocacy@aabb.org for additional information.