Statement from the American Clinical Laboratory Association on the FDA Discussion Paper on LDTs
WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) – the nation’s largest organization representing the public policy interests of clinical laboratories – is reviewing the discussion paper on laboratory developed tests (LDTs) released today by the Food and Drug Administration (FDA).
“ACLA applauded the FDA’s recent announcement that it would not issue a final guidance on LDTs, and importantly we note that today’s document is not an official nor enforceable policy from the agency,” said Julie Khani, president of ACLA. “We have consistently maintained that LDTs are not medical devices and cannot and should not be regulated as such. The clinical laboratory community is pleased the FDA acknowledges that stakeholder input and the ongoing bipartisan work by Congress is the appropriate process to advance comprehensive reform of the LDT regulatory framework.”
Khani added that ACLA looks forward to working with Congress, the Administration, patients and other stakeholders on diagnostic reform that avoids duplication, promotes innovation and advances patient care.
# # #
The ACLA is a not-for-profit association representing the nation’s leading national, regional and esoteric clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies.