FDA Sets Up Webinar To Defend Its Controversial LDT Rule, Field Questions From Skeptics

By Jessica Karins / October 19, 2023 at 12:37 PM

FDA’s decision to propose a rule asserting its authority over laboratory-developed tests (LDTs) sets up a showdown with Congress and potential lawsuits from clinical labs over the agency’s ability to regulate the products as medical devices, and the agency has set up an unusual meeting in the middle of the rulemaking process to defend its approach and field questions from stakeholders.


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