Device Amendments News Today

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,...

We will explore the history of FDA’s regulation of software-enabled medical devices and stand-alone software and the agency’s more recent progress with digital health policies.

In anticipation of FDA’s virtual public workshop on transparency of artificial intelligence/machine learning (AI/ML)-enabled medical devices scheduled for October 14, 2021, we will be...

Health your username January 26, 2021 On Monday in the Northern District of Texas, two individuals filed a complaint against DePuy Orthopaedics Inc., Johnson & Johnson, and affiliated entities that claimed that the defendants knowingly continue to manufacture, market, and sell a hip implant device that allegedly caused harm, in the form of “debilitating pain” and increased blood levels of certain metals. The medical device in question, called the pinnacle device, is a Class III hip implant...

Location Live Online Join the conversation on Twitter using #CatoHealth. Follow @CatoEvents on Twitter to get future event updates, live streams, and videos from the Cato Institute. If you have questions or need assistance registering for the event, please email our staff at events@​cato.​org. When in November 2020 the Food and Drug Administration (FDA) proudly announced that it had approved the first at‐​home self‐​administered test for COVID-19, there was one catch...