Medical Device Reporting (MDR) under 21 CFR Part 803 requires manufacturers, importers, and device user facilities to report adverse events and product problems to the FDA. Compliance with MDR regulations…
Proper device classification and regulatory pathway determination are essential first steps for marketing medical devices in the United States. The FDA classifies devices as Class I, II, or III, based…
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…