WASHINGTON, D.C. – This week, the Advanced Medical Technology Association (AdvaMed), the world’s largest trade association representing medical device manufacturers, sent a letter urging House Energy and Commerce and Senate Health, Education, Labor and Pensions leaders to enact diagnostics reform provisions (The VALID Act) in the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022.
The letter, signed by 46 stakeholder groups who have collaborated with committee and congressional leaders on this reform, highlights the bipartisan, bicameral support the provision has received in recent months as the committees finalize the legislative package reauthorizing FDA’s user fee programs.
From the letter: “We appreciate your continuing efforts to deliver vital funding to the U.S. Food and Drug Administration (FDA), and we ask that as you reconcile differences between the user fee reauthorization legislation passed by the House Committee on Energy and Commerce and the Senate Committee on Health, Education, Labor and Pensions (HELP), you address an urgent public health issue by enacting the diagnostics reform provisions included in the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022
“As you are aware, the [VALID Act] addresses a longstanding issue that has been recognized by administrations of both parties. The current federal approach to oversight has fueled regulatory uncertainty that jeopardizes investment in the next generation of diagnostics that will provide for improved patient outcomes. As Congress finalizes a legislative package reauthorizing FDA’s user fee programs, it can also seize this truly unique opportunity to advance a flexible, risk-based regulatory system for all in vitro clinical tests. We appreciate your continued support for meaningful diagnostics reform and we remain committed to working with you and the committees to advance this legislation into law this year.”
Read the full letter to Congressional leaders here.
# # #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. For more information, visit www.advamed.org.
Editor’s Note:
Signatories to the letter include AZBio and the following AZBio Member Companies: American Cancer Society Cancer Action Network (ACS-CAN), BD (Beckton, Dickinson and Company), and Roche Diagnostics.