The U.S. Food and Drug Administration (FDA) recently issued a Letter to Industry warning medical device manufacturers and device study sponsors (“device firms”) of a source of “fraudulent and unreliable laboratory testing...more
When it comes to discussing medical devices regulated by the U.S. Food and Drug Administration (FDA), words such as “approved” and “cleared” cannot be used interchangeably as these terms carry a particular meaning....more
The US Food and Drug Administration is working to facilitate emergency use authorization for coronavirus (COVID-19) medical devices, including diagnostic tests and respirators, while also working with the Federal Trade...more
Over the past several months, the Food and Drug Administration (FDA) has issued several Warning Letters related to Investigational Device Exemption (IDE) requirements and misbranding. An IDE allows an investigational device...more