COVID-19
The Food and Drug Administration (FDA or the Agency), the US authority responsible for medical devices, issued guidance dedicated to formal meetings and user fee applications for medical devices in the context of the outbreak of the Coronavirus Disease 2019 (COVID-19)...
FDA
The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, issued guidance on supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) submissions in the context of the outbreak of the...
North America
The US Food and Drug Administration (FDA) finalized guidance on the Humanitarian Device Exemption (HDE) program on Thursday, reflecting amendments made by the 21st Century Cures Act (Cures Act) and the FDA Reauthorization Act (FDARA). What is the HDE program? The HDE...
