The Food and Drug Administration, FDA's Center for Devices and Radiological Health regulates medical devices and requested comments for expanding patient access patient access. CDRH has increasingly focused on health equity as a driver for medical device regulatory policy.
FDA’s Center for Devices and Radiological Health has published two draft guidance documents in anticipation of the end of the public health emergency brought about by the COVID-19 pandemic. Devices subject to the guidances should consider reviewing these documents carefully.