AdvaMed Statement on HHS Reversal of LDT Rescission Notice
WASHINGTON, D.C. – Today, the Advanced Medical Technology Association (AdvaMed) released the following statement from President and CEO Scott Whitaker following the Department of Health and Human Services’ announcement regarding new requirements for laboratory-developed tests (LDTs):
“We are pleased that the Administration reversed this rule. We have long supported the idea that all diagnostic test developers – whether they make in vitro (IVDs) or laboratory developed tests (LDTs) – should be subject to the same FDA standards and processes. We support the VALID Act to modernize the law in this regard, so that patients can have the confidence they deserve to have in every test they’re given.”
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AdvaMed member companies produce the medical devices, diagnostic products and digital health technologies 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.