pharmaphorum
SEPTEMBER 29, 2022
Kyle helps companies build and refine corporate compliance programs, including advising clients on regulatory and compliance matters involving the Food, Drug and Cosmetic Act, the False Claims Act, the Anti-Kickback Statute, the AdvaMed Code and the PhRMA Code.
FDA Law Blog
NOVEMBER 1, 2023
Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Lenz, Principal Medical Device Regulation Expert & Sophia R. Gaulkin & Jeffrey N.
FDA Law Blog
OCTOBER 6, 2023
The amended regulation would read as follows (revisions underlined): In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or prevent disease or its sequelae.
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