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Home » FDA’s draft rule on lab-developed tests not necessarily the last word
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FDA’s draft rule on lab-developed tests not necessarily the last word

Oct. 2, 2023
By Mark McCarty
The U.S. FDA has finally let fly with a draft rule for regulation of lab-developed tests (LDTs), an 83-page document that delves into the legal controversies regarding whether the agency has the requisite statutory authority. However, Allyson Mullen, a director in the D.C. office of Hyman, Phelps & McNamara P.C., told BioWorld that the emergence of this draft rule doesn’t mean Congress won’t eventually be dragged back into the LDT fray, particularly if stakeholders litigate to overturn the draft.
BioWorld MedTech Regulatory Diagnostics U.S. FDA

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