USA – Device importers’ COVID questions answered by FDA

The US Food and Drug Administration (FDA) has launched two new webpages related to medical device importation, registration and listing during the COVID-19 pandemic.

The first webpage addresses registration and listing of medical devices, answering frequently asked questions (FAQs) about what is required, and what procedures should be followed, during the pandemic.

In the question-and-answer format, FDA collates information and guidance documents pertinent to operations during the pandemic. Device-specific guidances are available for some ventilators and personal protective equipment that clarify FDA’s intent to enforce registration and listing requirements during the public health emergency.

The FAQ page also directs industry to its list of emergency use authorizations (EUAs); facilities whose devices have an EUA “should review the EUA letter of authorization to determine whether the FDA requires you to register and list,” according to the FAQ.