What is the FDA’s 510(k) Process?
The Food and Drug Administration (FDA) was founded in 1906, but it wasn’t until 1938 in the wake of the Sulfanilamide Disaster that Congress passed the Federal Food, Drug and…
The Food and Drug Administration (FDA) was founded in 1906, but it wasn’t until 1938 in the wake of the Sulfanilamide Disaster that Congress passed the Federal Food, Drug and…
Of the two pathways available to medical device manufacturers seeking FDA approval for new products, the 510(k) process is the cheaper and significantly faster route. But, how safe is it?…