Getting a medical device cleared by FDA for sale in the US is typically a lengthy process. The average FDA 510(k) submission takes 5+ months to clear from the time of submission, and that’s not including the prep work. When the COVID-19 pandemic hit, FDA understood the need to vastly speed up the approval process for certain types of equipment used to detect/protect/treat patients with COVID-19 and the healthcare workers caring for them. This is why FDA declared an Emergency Use Authorization (EUA) pathway for certain items related to COVID-19. EUAs have recently been issued by FDA for the following products:

• Personal Protective Equipment (PPE) – masks, face shields, decontamination systems, etc. (Note: Umbrella EUAs for Imported Disposable Filtering Facemasks (N95) and decontamination systems were revoked June 30, 2021).
• In Vitro Diagnostics (IVD) for detection and/or diagnosis of COVID-19, including highly complex molecular-based Lab-Developed Tests (LDT)
• Ventilators and other critical medical products

We’ll help you determine if the FDA EUA is a viable option for your medical device or IVD

If you have already checked out FDA website, you have probably already figured out that getting EUA approval is not as clear-cut as you may have hoped. The FDA details the requirements for medical devices in a 49-page EUA guidance document and has separate “pre-EUA” submission guidance for IVDs. Oriel STAT A MATRIX understands that you want to put your products to work as fast as possible and not waste precious time trying to figure out the process. We know how the EUA process works and are ready to help you make sense of it right away! Here are the steps:

• PHASE 1 – Document review, gap analysis, and strategy
• PHASE 2 – Data generation, testing, and FDA meeting (if required)
• PHASE 3 – Compile EUA submission and submit to FDA
• PHASE 4 – Post-submission support

Increasing your odds of a successful FDA EUA submission

Making sure you are ready for an EUA submission is critical or you’ll waste valuable time. FDA is very responsive to EUA submissions, but they are certainly not looking to approve experimental products, there is no time for lengthy exploratory phone conferences, and FDA has no patience for incomplete submissions. They want solid submissions for relatively mature products that have demonstrated safety data and are in the advanced stages of efficacy testing. We can assist you in making sure that your submission is rock-solid ready for FDA review. In some cases, FDA will request that you participate in a pre-EUA application to discuss specific items surrounding product testing and clinical expectations. The pre-EUA is the first step to an ongoing interactive application leading to an EUA. We can assist you through this process, as well.

Contact us today and shorten your time to EUA submission

We have helped numerous medical device and IVD companies with FDA Emergency Use Authorizations in response to COVID-19 and are ready to help you too. For fastest response, call us at 1.800.472.6477 or submit an inquiry online.