US FDA publishes FAQs on registering and importing devices during COVID-19

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.

Registering and listing medical devices and facilities

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:

• Registration and Listing During the COVID-19 Pandemic
• Confirming Registration and Listing Information
• Registration and Listing of Certain Medical Devices for Use During the Emergency

Importing medical devices

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:

• Importing Respirators, Face Masks, and PPE
• Donating Medical Devices
• Importing Other Medical Devices
• Checking Import Status and Contact for Import Questions

Related regulatory resources for US FDA and COVID-19:

• US FDA Emergency Use Authorization pathways for medical devices and IVDs
• COVID-19 Resource Center
• US FDA QSR quality management system (21 CFR Part 820) compliance consulting
• US FDA 510(k) registration consulting for medical device and IVD companies
• Webinar: Conducting safe in-person testing during COVID-19
• Webinar: Latest FDA expectations for human factors validation tests of combination products