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.

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.

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 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 ...

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

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 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 ...

The Food and Drug Administration said Friday it will now require import certification for shrimp and spices from certain regions of Indonesia following a bout of shrimp recalls related to radioactive ...

The new OnePlus Watch 3 looks promising, but US users won't get the same features Notably, ECG support won't be included ...

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