Healthcare systems in North America and Europe are increasingly favoring suppliers who can provide “one-stop” solutions—meaning products that transition seamlessly from emergency stabilization to long ...

The FDA is moving forward surprisingly quickly with its plan to create a pre-certification program for digital health app developers, originally announced in a blog post by new FDA Commissioner Dr.

This is an archived article and the information in the article may be outdated. Please look at the time stamp on the story to see when it was last updated. MINERVA, Ohio (WJW) – A local company has ...

Recently, the U.S. Food and Drug Administration, or the FDA, announced enhancement of the FDA's Paragraph IV Patent Certification List (the List) as part of the agency's stated goal of bringing more ...

On October 3, 2025, the U.S. Food and Drug Administration (FDA) announced that it will begin requiring import certifications for shrimp and all spices from certain regions of Indonesia based on the ...

An Instagram ad catches your eye. You click to the product’s website and find reassurance: The product, it says, is "FDA certified" or was "produced in an FDA registered facility." Mention of the U.S.

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...

The ANSI-ASQ National Accreditation Board (ANAB) recently notified the US Food and Drug Administration that LSQA SA of Montevideo, Uruguay now is accredited as a certification body (CB) by ANAB under ...

The U.S. Food and Drug Administration Commissioner Scott Gottlieb offered a preview of a new Digital Health Innovation Plan in a blog post this week. It will clarify how the FDA regulates digital ...

The FDA may get a role in certifying electronic health records because of that agency's long history of monitoring other products for patient safety. The certification workgroup of the federal Health ...

Corporate image representing Global Certification Development Research Institute (GCDRI) delivering ISO certification ...

FDA announced a pilot program that might result in a "pre-certification" for digital health startups. That would provide some much-needed clarity for digital health startups, and a potential ...