Modernizing the Regulatory Framework for Clinical Diagnostics 

Current regulatory oversight of the development and quality of diagnostic tests is outdated and fragmented. Lagging behind scientific advances and the increasing complexity of testing, present regulation is based not on the tests themselves, but rather on where the test is developed, leading to inconsistencies in the accuracy and reliability of tests for clinical decision making. 

Modernization of the regulation of all LDTs and IVDs under a single, diagnostic-specific regulatory framework under the Food and Drug Administration (FDA) is needed to foster innovation, embrace scientific advances, ensure consistency in development, accuracy and reliability of all tests, for the advancement of patient care and public health. Under a modernized new framework, LDTs and IVDs would be known collectively as in vitro clinical tests (IVCTs). 

AdvaMedDx supports the establishment, through legislation, of a modernized and predictable, risk-based diagnostics regulatory framework under the Food and Drug Administration (FDA) to which all developers of in vitro clinical tests (IVCTs) would be subject. Under a modernized new framework, Laboratory Developed Tests (LDTs) and In Vitro Diagnostics (IVDs) would be known collectively as IVCTs. 

In the last Congress, the introduction of the Verifying Accurate, Leading-edge IVCT Development (VALID) Act by Sens. Richard Burr (R-NC) and Michael Bennet (D-CO) in the Senate, and Reps. Diana DeGette (D-CO) and Larry Bucshon, MD (R-IN) in the House, is a major milestone toward modernizing IVCT oversight, making diagnostics regulatory reform a reality.  

The VALID Act, poised to be reintroduced in the 117th Congress, would seek to establish a single, diagnostics-specific, risk-based regulatory framework under the FDA for all IVCTs. AdvaMedDx will seek to advance comprehensive diagnostics reform legislation in this Congress. 

VALID Act Resources

The resources below pertain to the VALID Act as introduced in the last Congress. We await reintroduction of a new VALID Act in this new Congress in 2021. 

Mobilize for MedTech

Join AdvaMed’s grassroots campaign to effect change and ensure patients have timely access to life-changing technologies.