We write to you regarding the District Court for the Eastern District of Texas’s March 31 decision in an industry-initiated lawsuit challenging FDA’s authority to regulate Laboratory Developed Tests (LDTs). As you know, the court ruled, in its primary finding, that LDTs are services, not devices, thereby setting aside a final rule that had been in the works at FDA for years. We expect the Agency is concerned about an opinion that removes authority from FDA over an important subset of medical products and erodes the Agency’s authority to ensure safe and effective diagnostics are on the market.
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Government Accountability