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AdvaMed statement on introduction of Bipartisan VALID Act

Press releases may be edited for formatting or style | March 31, 2023
WASHINGTON – Today, AdvaMed, the medtech association, released the following statement from President and CEO Scott Whitaker on the introduction of the bipartisan Verifying Accurate, Leading-edge IVCT Development (VALID) Act. Introduced in the House of Representatives by Congressman Larry Bucshon (R-Ind.) and Congresswoman Diana DeGette (D-Colo.), the VALID Act modernizes regulatory oversight of in vitro clinical tests (IVCTs) – including in vitro diagnostics (IVDs) and laboratory-developed tests (LDTs).

“Last year, the bipartisan VALID Act was nearly passed by Congress and enacted, a long-overdue modernization of the regulatory framework of diagnostics. With the reintroduction of this important legislation in the new Congress, there is a path to getting it over the finish line this year. These reforms are an important step toward ensuring patients continue to have access to accurate, reliable diagnostic tests. We thank Reps. Bucshon and DeGette for their continued leadership on this important issue, and I look forward to working with them and other stakeholders to ensure that this legislation becomes law and that patients across the country have access to the best possible diagnostic tests.”

“Modernization of the regulation of all LDTs and IVDs under a single, diagnostic-specific regulatory framework under the Food and Drug Administration is needed to foster innovation, embrace scientific advances, and ensure consistency in development, accuracy and reliability of all tests, for the advancement of patient care and public health,” said Zach Rothstein, Executive Director of AdvaMedDx, the division of AdvaMed representing medical diagnostic companies. “We are grateful for the continued leadership of Congressman Buschon and Congresswoman DeGette on this critical issue.”

AdvaMed, the world’s largest trade association representing medical technology companies, has long championed the passage of the VALID Act, last year urging Congressional leaders to include it in the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022 and submitting RFIs to lawmakers this month ahead of introduction of the bill.

Additionally, former FDA Commissioners Dr. Scott Gottlieb and Dr. Mark McCelellan, in an op-ed in the Journal of the American Medical Association last year, called for an overhaul of diagnostic test regulations. From the op-ed: “The proposed FDA legislation creates a modern framework uniquely tailored to diagnostic tests and the rigor taken by the entities that develop them, including a new pathway to allow the FDA to take a laboratory- or company-based approach to regulation. The FDA would oversee the process used to develop and validate tests, rather than regulating only the tests themselves. Laboratories with good procedures for ensuring the reliability of their tests would, in many cases, be able to market new tests and iterations of existing platforms without undergoing the same premarket adjudications. At the same time, the new pathway would give the FDA clear authority to oversee tests and ensure that all tests meet certain common requirements for demonstrating that they reliably produce the molecular and genomic findings that they are intended to generate.”

AdvaMed member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. AdvaMed members range from the largest to the smallest medical technology innovators and companies.

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