With the new LDT final rule, FDA works to clarify what emergency response will look like going forward


The Covid-19 pandemic highlighted some gaps in existing policy for how tests and diagnostics are regulated and deployed in emergency situations. The FDA recently issued a new rule to overhaul its enforcement policies for laboratory developed tests (LDTs), and has also issued two accompanying guidance documents outlining implications and new expectations for emergency response and what an emergency-related enforcement discretion would potentially look like going forward.

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