FDA Clarifies Registration, Listing Requirements for Medical Device Manufacturing Facilities During 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.

View the FDA’s webpage on the registration and listing of medical devices during the COVID-19 Pandemic.

View the FDA’s webpage on the importation of medical devices during the Pandemic.

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