ACLA Statement on Reintroduction of the VALID Act

Washington, D.C. – Following the reintroduction of the Verifying Accurate Leading-edge IVCT Development (VALID) Act of 2021, ACLA President Julie Khani issued the following statement:

“ACLA is currently reviewing the VALID Act with our members. As the COVID-19 pandemic has illustrated, a clear and nimble regulatory framework with pathways that do not unnecessarily impose regulatory burdens on test development is essential to public health and patient care. To best serve patients, laboratories need clarity and certainty in the regulatory environment. This certainty is critical to encourage innovation and the next generation of breakthrough technologies, and to support continued patient access to accurate and reliable laboratory developed tests necessary to diagnose, monitor and optimize the treatment of disease.

Over the last several years, ACLA has been working closely with policymakers and other stakeholders to advance diagnostic reform for patients. Specifically, ACLA has consistently advocated for three key priorities: 1) risk-based reform that calibrates regulatory controls to the risk posed by the diagnostic test and which applies standards specific to diagnostics, rather than standards developed for medical devices; 2) appropriate grandfathering and transition policies that preserve patient access to currently available laboratory tests, many of which are currently the gold standard in clinical practice; and 3) a transparent and accountable regulatory system, implemented through notice-and-comment rulemaking, that balances the needs of innovation and appropriate regulatory oversight to ensure the accuracy, reliability and access of these tests.

We commend Sen. Michael Bennet (D-CO), Sen. Richard Burr (R-NC), Rep. Diana DeGette (D-CO) and Rep. Larry Bucshon (R-IN), for their continued leadership and attention to this critical issue and look forward to continuing to work together to improve the care available to all Americans.”

Read more: ACLA’s letter to Secretary Becerra on the regulation of Laboratory Developed Tests (LDTs); ACLA’s comments on VALID Act of 2020.


The American Clinical Laboratory Association (ACLA) is the national trade association representing leading laboratories that deliver essential diagnostic health information to patients and providers. ACLA members are at the forefront of driving diagnostic innovation to meet the country’s evolving health care needs and provide vital clinical laboratory tests that identify and prevent infectious, acute and chronic disease. ACLA works to advance the next generation of health care delivery through policies that expand access to lifesaving testing services.

Print page / Save as PDF