On August 19, Justin Coen, Jeremiah Kelly, and Laura Rich published “The Future Of Lab-Test Regs After FDA Rescinds Rule” in Law360. The following is an excerpt:
On Aug. 6, the U.S. Food and Drug Administration rescinded its final rule on laboratory-developed tests. The development follows the U.S. District Court for the Eastern District of Texas' March 31 decision vacating the rule, holding in American Clinical Laboratory Association v. FDA that the agency lacked authority to regulate LDTs as medical devices under the Federal Food, Drug and Cosmetic Act.
The core of the court's opinion was that Congress created a distinct regulatory scheme in 1988 through the Clinical Laboratory Improvement Amendments, or CLIA, vesting oversight authority for laboratory testing with the Centers for Medicare & Medicaid Services, not the FDA.
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