FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the early collaboration meetings in the context of the FDA Modernization Act (FDAMA). The latest version...
North America
De Novo classification, also known as Evaluation of Automatic Class III Designation, is a risk-based classification process of novel devices for which there are no legally marketed predicate devices. Under this program, products are automatically classified as Class...
North America
The Safe Medical Devices Act of 1990 (SMDA) is a federal law that requires manufacturers and user facilities and to report any adverse events associated with a medical device to the FDA. In 1997, the SMDA has renamed the FDA Modernization Act (FDAMA). This policy...
