Sep 2, 2020
The US FDA published two FAQ documents in August, answering questions about registering, listing, and importing medical devices during the COVID-19 emergency. These should be useful to manufacturers and other interested parties, not only because of the question-and-answer format, but because they provide links to numerous other FDA guidance documents published during the pandemic and related online resources.
The first FAQ describes requirements and approved procedures for registering and listing medical devices and facilities during the COVID-19 pandemic. It includes an explanation of how to confirm registration and listing information, and it also provides recommendations and guidance documents relevant to operations during the present public health emergency. The FAQ addresses topics such as how long it takes for a facility to receive its registration number, when registration is not required, and how to evaluate claims of FDA “certification.” The section headings are as follows:
The second FAQ looks at importing medical devices amidst the COVID-19 emergency. It addresses importation of specific devices that have been issued with Emergency Use Authorizations (EUAs) and devices for which an enforcement decision has been published in a guidance document. This FAQ also includes detailed instructions for donating medical devices, checking import status, evaluating FDA “certification” claims, and identifying contacts for import questions. Section headings are:
Normal requirements for regulatory submissions or notification periods will be waived in certain cases impacted by the COVID-19 crisis.
The US government body is seeking input from stakeholders about products and technologies that could play a role in limiting the coronavirus outbreak.
US FDA's Emergency Use Authorization (EUA) pathway allows rapid market entry for medical devices in short supply