FDA
The European Commission issued a Question and Answer document in order to provide medical device manufacturers with the information regarding the way the new Manufacturer Incident Report (MIR) Form shall be implemented. New Manufacturer Incident Report Form in Brief...
FDA
The Food and Drug Administration (FDA), the United States’ authority for medical devices regulation, issued home specimen collection molecular diagnostic template in order to provide medical device manufacturers with the recommendations related to the content of...
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...
FDA
The Food and Drug Administration (FDA) issues Emergency Use Authorizations (EUAs) in order to expand the availability of vitally important medical devices during the outbreak of the Coronavirus Disease 2019 (COVID-19). The outbreak of the aforementioned disease,...
FDA
The Food and Drug Administration (FDA), the US authority responsible for medical devices regulation, has recently published a transcript of the final guidance dedicated to the 510(k) Third Party Review Program (3P510K). The document follows the initial guidance on...
FDA
The Center for Devices and Radiological Health (CDRH), the unit of the Food and Drug Administration (FDA) responsible for medical devices regulation, issued guidance describing how medical device manufacturers should notify CDRH of a permanent discontinuance or...
