Senate Bill Proposes Laboratory Developed Tests to Be Regulated under CLIA Process

On March 17, 2020, Sen. Rand Paul introduced S. 3512, the Verified Innovative Testing in American Laboratories (VITAL) Act of 2020. According to Sen. Paul, the VITAL Act would help diagnostic and prognostic tests become available more quickly during public health emergencies by securely placing laboratory-developed testing services solely under the oversight of the Center for Medicare and Medicaid Services (CMS) pursuant section 353 of the Public Health Service Act, as updated by the Clinical Laboratory Improvement Amendments (CLIA provisions). At the same time, the VITAL Act would exclude FDA from any oversight role in regard to laboratory-developed testing procedures, even during a public health emergency. This bill is in contrast to the Verifying Accurate, Leading-edge IVCT Development (VALID) Act, introduced into the House on 5 March 2020, which would install a regulatory framework for a new product paradigm called in vitro clinical tests (IVCTs), encapsulating laboratory-developed tests (LDTs), traditional in vitro diagnostics (IVDs) assays sold to laboratories by manufacturers, and other tests and test components. Under the VALID Act, IVCTs would all be regulated by FDA.

Source: https://www.jdsupra.com/legalnews/senate-bill-proposes-laboratory-41772/