ACLA Commends FDA Decision Not to Release Final LDT Guidance, Looks Forward to Continuing to Work with Congress and the Incoming Administration on Reform that Puts Patients First

WASHINGTON, D.C. – The American Clinical Laboratory Association (ACLA) applauded today’s announcement by the Food and Drug Administration (FDA) that it will not release a final guidance to regulate laboratory developed tests and instead work with Congress and other stakeholders to determine the best solution to reform.

“The FDA’s decision not to issue final guidance to regulate LDTs is a victory for diagnostic innovation and most importantly, patients,” said Alan Mertz, ACLA President. “We appreciate the FDA’s acknowledgement that stakeholder input and the ongoing bipartisan work carried out in the House and Senate is the appropriate process to advance comprehensive statutory reform of the LDT regulatory framework.”

In response to the FDA’s efforts to use the agency’s medical device authority to regulate LDTs, ACLA has consistently maintained that LDTs are not medical devices and cannot be regulated as such.

“Today’s announcement by the FDA has paved the way for a transparent discussion on meaningful reform that would protect diagnostic innovation and patient access,” concluded Mertz. “The clinical laboratory community looks forward to working with all stakeholders as diagnostic innovation continues to be front and center in the advancement of medical science.”



About the American Clinical Laboratory Association

The American Clinical Laboratory Association (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.

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