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ACLA Sues FDA To Block New LDT Oversight

Of Counsel Benjamin Zegarelli shared key insights with MD+DI on the American Clinical Laboratory Association’s (ACLA’s) lawsuit against the FDA for their laboratory-developed test (LDT) ruling.

Benjamin commented on previous LDT enforcement, stating since 1988, “LDTs and the clinical laboratories that develop and commercialize them have had to comply with CLIA and state laws relating to laboratory operations but were not required to comply with FDA’s medical device regulations due to the agency’s historical policy of enforcement discretion for LDTs.”