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

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.

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 ...

On January 3, 2023, FDA released an updated Risk Evaluation and Mitigation Strategy (REMS) for mifepristone. The updated REMS follows a December 2021 FDA announcement that it would eliminate the ...

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 Apple Watch series AFib feature has received new approval from the FDA. From now on, the results returned by the devices are considered medical grade. Previously, the results could be considered ...

FDA issued a proposed rule today to increase fees for color additive certification services. If finalized, it will implement a 10-cent-per-pound increase in color certification fees and revise the ...

OnePlus is looking for FDA approval for its Sleep Apnea detection feature The OnePlus Watch 3 launched without FDA ...

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 ...