An Investigational Device Exemption (IDE) allows medical device manufacturers to conduct clinical trials in the United States using investigational devices that have not yet received FDA clearance or approval. IDE…
The De Novo classification pathway is designed for novel, low- to moderate-risk medical devices that do not have a predicate device for 510(k) submission. This pathway allows manufacturers to obtain…
Bringing a pharmaceutical product to the U.S. market requires rigorous regulatory approval by the U.S. Food and Drug Administration (FDA). For drug manufacturers, this process involves filing either an Abbreviated…