FDA’s Lab-Developed Test Rule: Will New Leadership Bring Change?
The clinical lab industry is watching closely to see if President Trump’s return to office could impact the FDA’s final rule on lab-developed tests (LDTs). While changes are possible, especially if court rulings favor LDT proponents, a quick reversal seems unlikely. Congress or the VALID Act may offer alternative pathways, but for now, labs must prepare to comply with FDA regulations.
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