Rush or Wait? The EUA Dilemma – Elexes
Elexes Medical Consulting

FDA Emergency Use Authorization (EUA) program is a great way to help out in an emergency situation, whether it is for diagnosis, monitoring patient’s vitals, or treating the patients suffering from COVID 19. One of the best ways to give back.

While an EUA is a NO BRAINER for companies with product portfolios, there are some things for a startup to consider.

The products are authorized for use under an EUA only until the emergency situation lasts and the applicability expires once the FDA terminates the emergency.
Manufacturers of EUA devices with no other FDA approval will have to dispose of their product, however, others will go back to “normal use”.
Timelines of the approvals are case dependent, “within hours or days” provided all necessary data is submitted. Important part is “all necessary data” to sufficiently demonstrate the product’s benefits and risk profile.

Here is a practical decision tree to help you decide.

“RUSH” indicates it’s time to quickly begin understanding what information is needed and pursue an EUA.

“WAIT” indicates it would be better to pursue a 510 k, PMA or DeNovo.

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