Help Protect Patient Access to Laboratory Developed Tests
ASCP needs your help to protect Laboratory Developed Tests—tests developed or modified within clinical laboratories—from overregulation.
Congress is currently working to reauthorize the Medical Device User Fee Amendments (MDUFA), which sets the fees for U.S. Food and Drug Administration (FDA) approval of medical devices—like commercial laboratory tests. As part of this process, Congress is considering including the Verifying Accurate Leading-edge IVCT Development Act (VALID) in the MDUFA legislation. The VALID Act would significantly increase authority over laboratory developed tests, or LDTs.
Rather than being regulated under the Clinical Laboratory Improvement Amendments of 1988, as is currently the case, the VALID Act could subject these tests to the same regulatory requirements as commercial diagnostics. This would expose LDTs to expensive approval fees, pre-market approval, and other regulatory requirements—a possibility that would deter many clinical laboratories from developing and offering these innovative and critical diagnostics to their patients.
The VALID Act is a complex piece of legislation with significant ramifications for clinical laboratories and it requires thoughtful consideration that is separated from the political needs to fund FDA.
Help ensure that clinical laboratories can continue to provide LDTs to their patients by sending Congress a message to keep the VALID Act out of MDUFA.
Please use (or modify) the draft message in ASCP’s eAdvocacy Center to protect LDTs.
Not everyone gets ASCP’s action alerts. Please forward this message on to your colleagues and urge them to take action too. Thank you.
For more information on ASCP’s recent actions to keep the VALID Act out of MDUFA, click here.
