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FDA has provided updated clarification on its requirements & listing of facilities used for the production of medical devices during the current COVID-19 Pandemic

The U.S. Food and Drug Administration (FDA) has provided updated clarification on its requirements regarding the registration and listing of facilities used for the production of medical devices during the current COVID-19 Pandemic.

Updated as of mid-August, the FDA’s webpage adopts a “question and answer” format to offer detailed answers on facility registration and listing issues relevant to manufacturers and importers of medical devices. Covered topics include the registration and listing process, confirming registration and listing information, and the potential use of the emergency use authorization (EUA) process in specific cases.

Separately, the FDA has also updated its webpage on the importation of certain types of medical devices during the current Pandemic. Importation information available on this webpage includes that applicable to respirators, face masks and personal protective equipment (PPE). The webpage also includes information on importing other types of medical devices, such as sterilizers, disinfectant devices and air purifiers.

Sandesh Ilhe
Sandesh Ilhe
With an Engineers degree in Advanced Database Management and Information Security, Sandesh brings the deep understanding of the digital world to the table. His articles reflect the challenges and the complexities that come along with every disruption in the industry. He carries over six years of experience on working with websites and ensuring that the right article reaches the right reader.