http:https://www.congressweb.com/associationmp Fri, 02 May 2025 02:25:12 GMT http:https://www.congressweb.com/associationmp/19 <div> <div>On Feb. 21, U.S. Reps. Brad Finstad, R-Minn., and Dan Crenshaw, R-Texas, introduced the Freedom for Laboratory Innovation and Testing Act, legislation that would prevent any federal funding from being used to implement the Food and Drug Administration (FDA) final rule on laboratory-developed testing procedures (LDTs).</div> <div>&nbsp;</div> <div>The final rule on LDTs inappropriately defines laboratory services as medical devices, subjecting them to regulation and effectively treating laboratory professionals as manufacturers. This approach will impose the burdensome and time-consuming FDA premarket review process for medical devices upon LDTs, along with unnecessary or redundant requirements related to registration and listing, package labeling, manufacturing quality control and product recalls. These requirements are ill-suited for laboratory services, which are validated processes that rely upon expertise-driven oversight and analysis that factors in patient needs and evolving and variable clinical contexts. Moreover, the implementation of the rule is an upheaval of the long-standing, successful regulatory approach through the Clinical Laboratory Improvement Amendments (CLIA) program administered by the Centers for Medicare and Medicaid Services (CMS), which focuses on continual quality assurance, personnel qualifications, and testing accuracy, ensuring patient safety without the inappropriate constraints of medical device regulations.</div> <div><br /> AMP is deeply concerned that the final rule on LDTs will significantly harm innovation and access to patient care. For these reasons, we applaud Reps. Finstad and Crenshaw for introducing the Freedom for Laboratory Innovation and Testing Act to halt the rule. Please join AMP in asking members of the House of Representatives to join as a co-sponsor and support this important legislation!</div> <div>&nbsp;</div> </div> Wed, 19 Mar 2025 04:00:00 GMT http:https://www.congressweb.com/associationmp/19