AdvaMed Urges Congress to Pass VALID Act by Year’s End

AdvaMed, joined by eight health advocacy groups, sent a letter to Congressional committee leaders urging year-end passage of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, which was dropped from the user fee reauthorization package passed Sept. 30.

Passage of the act would give the FDA regulatory oversight of both laboratory developed tests (LDTs), currently overseen by the Centers for Medicare & Medicaid Services (CMS), and in vitro diagnostic tests (IVDs), for which the FDA is currently responsible. IVCT in the act’s name stands for in vitro clinical tests, a new category encompassing both types of tests. 

The VALID Act’s reforms include using a risk-based approach to determine the need for premarket review, test precertification, adverse event reporting, and other regulatory requirements. Tests would be classified as high or low risk — to an individual or to public health — with similar pathways to approval as the existing premarket approval (PMA) process. 

One major change is that a developer of a low-risk test could file a precertification application which would exempt the test from premarket review for two years, allowing more rapid advancement to marketing.