FDA Seeks to Increase Regulatory Oversight of Laboratory Developed Tests

On October 3, the US Food and Drug Administration (FDA) issued a proposed rule regarding the regulation of in vitro diagnostic products (IVDs). In this proposed rule, the FDA announced its intent to amend its regulations to provide that laboratory developed tests (LDTs) are medical devices under the federal Food, Drug, and Cosmetic Act (FDCA) and are subject to all accompanying regulations….
By: ArentFox Schiff