COVID-19
The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, has issued a final version of the guidance dedicated to the multiple function device products. Regulatory Background The regulatory framework to be applied for a...
COVID-19
The Food and Drug Administration (FDA) has published a new template for emergency at-home and over-the-counter diagnostic COVID-19 tests and medical devices for use in non-lab settings, such as homes, offices, or schools. FDA: Regulatory Background In order to...
North America
The US Center for Devices and Radiological Health (CDHR), which is the branch of the FDA (the United States regulatory authority), issued a new Guidance on medical devices that generate images. The guidance includes recommendations mainly for medical equipment...
