WASHINGTON, Nov. 18, 2016 /PRNewswire-USNewswire/ -- The American Clinical Laboratory Association (ACLA) applauded today'sannouncement 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.
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 AssociationThe 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.
Contact: Rebecca Reid(410) 212-3843
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SOURCE American Clinical Laboratory Association (ACLA)
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