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.

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 ...

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 ...

This is an archived article and the information in the article may be outdated.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 ...

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 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 ...

Three Democratic senators are requesting additional information about the FDA’s Pre-Cert for Software Pilot Program, a streamlined regulatory pathway for digital health technologies that the agency ...

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 ...

FDA requests information to explore whether current gluten labeling rules adequately protect consumers, with implications for ...

The U.S. Food and Drug Administration (FDA) has instituted an import certification requirement for shrimp and spices originating from a specific region of Indonesia. This action follows the detection ...