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On April 29, 2024, the U.S. Food and Drug Administration announced a final rule that amends existing regulations to make explicit that in vitro diagnostic products and tests, including laboratory developed tests, are devices regulated under the Federal Food, Drug and Cosmetic Act.
The Food and Drug Administration's (FDA) proposed rule would change decades of Laboratory Developed Test (LDT) regulation by expressly considering these in vitro diagnostics (IVDs) medical devices.
In D’Addario v. Johnson and Johnson, the United States District Court for the District of New Jersey addressed express preemption principles in a product liability case involving Class III breast implants. The Court held the MDA expressly preempted state law claims.
Last week, the Food and Drug Administration (FDA) issued a safety communication warning the public about the potential risks of false results with genetic non-invasive prenatal screening tests (referred to as "NIPS" or "NIPT").
Genus Continues to Sow Confusion and May Prompt Congressional Action - For a court case involving arcane, but important, regulatory issues, Genus Medical Technologies,...