How to Study and Market Your Device Medical devices marketed in the United States are subject to the regulatory controls in the Federal...

The recall described in this notice is for the same issue that was announced in Potential for False Positive Results with Certain Lots of...

The U.S. Food and Drug Administration(FDA) announced the following actions taken in its ongoing response effort to the COVID-19 pandemic...

The following quote is attributed to Bakul Patel, director of FDA’s Digital Health Center of Excellence in the Center for Devices and...

Cosmetic products (such as soaps, lotions, face and eye make up, fragrances, etc.) can provoke allergic reactions in some people. Many...

Immediately and thoroughly rinse eyes with gently running water if this occurs What safety concern is FDA announcing? The U.S. Food and...

Dental implants are medical devices surgically implanted into the jaw to restore a person's ability to chew or their appearance. They...

Today, the U.S. Food and Drug Administration authorized the emergency use of the Pfizer-BioNTech COVID-19 Vaccine for the prevention of...

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19...

The following quote is attributed to Linda Katz, director of the FDA's Office of Cosmetics and Colors: “The FDA remains dedicated to...