‘The FDA Will Be Looking For Avenues To Regulate Laboratory Developed Tests’

Decentralized, Multiple Site LDTs Could Be At Risk, Says McDermott Will & Emery Lawyer

The FDA's final LDT ruling was struck down in federal court last month. For now, diagnostic companies can commercialize under CLIA regulations or apply for FDA approval. McDermott and Tribun Health have shared insights on the risks, pros and cons of both regulatory routes.

LDTs

The career staff at the US Food and Drug Administration (FDA) will be thinking hard about alternative potential avenues for the regulation of laboratory developed tests (LDTs), Michael Ryan, partner at McDermott Will & Emery, told the audience at the law firm’s annual European Health and Life Sciences Symposium, held in London on 3 April.

Ryan continued, “I would not be surprised to see the FDA try to take enforcement action against certain types of...

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