FDA News

Medical Device Reporting (MDR) under 21 CFR Part 803 is how the U.S. Food and Drug Administration (FDA) collects reports when a medical device is linked to a death, a serious injury, or a malfunction that could cause harm if it happens again. These reports feed into the MAUDE database, where the FDA tracks signals, issues Medical Device Safety Communications, and works with regulators to decide if actions like recalls, labeling updates, or market corrections are needed. Diff

Not every product that promotes health is exempt from FDA regulation. The agency’s General Wellness Guidance outlines what qualifies as a low-risk wellness device—and what crosses the line into regulated medical device territory. In this blog, we break down the FDA’s criteria, share examples of compliant products, and highlight recent enforcement actions against brands that misclassified their devices. What Is a General Wellness Device? According to the FDA, a general wellne

The FDA began regulating around the time they began to notice that the food and drugs that can sustain us can also be just as dangerous....

The FDA can be a thorn in the side of many medical device companies. The regulations could make your head spin. However, the FDA has only...