As noted in our earlier alert, the FDA continues to face mounting internal pressure, ranging from staffing reductions and ...

Despite recent staffing reductions and leadership transitions at the FDA, pharmaceutical and medical device manufacturers ...

Flow says approval delays persist for clinically validated depression devices, yet the US market is "flooded" with devices ...

The Food and Drug Administration (FDA) has urged the Department of Health (DOH) to approve the immediate suspension of an ...

The breadth of medical devices in terms of safety, it’s enormous. You have a pacemaker on one end and a tongue depressor on the other, and then FDA has to figure out a regulatory scheme that ...

In response, the U.S. Congress passed the Federal Food, Drug and Cosmetic Act of 1938, granting FDA with “premarket review” ...

However, the integration of AI into medical devices raises significant regulatory challenges. Ensuring that these ...