Since the COVID pandemic swept our nation, we have had several clients reach out to us and ask about our technical position on how COVID related devices (swabs, masks, etc.) should be evaluated.
In an article written by the FDA, they list surgical masks, face shields, respirators, gowns, and gloves as medical devices that are important for the defense against COVID and how their validation process may look different now since those devices need to arrive to the end user as fast as possible.
This article explains that there is a select scope of products in which the FDA is willing to grant Emergency Use Authorizations (EAU)s which fast-track the product for launch by waiving certain regulatory requirements. There is a unique EAU for each type of product, so there is not a one size fits all answer. Furthermore, you must apply to the FDA seeking permission to manufacture and distribute underneath the EAU and receive a letter back granting you access.
With all that said, our message to our customers is that the FDA still expects compliance with ISO 11607 and our typical project workflow or expectations is not affected. PCL will continue to provide the following services: Transit Testing, Accelerated and Real Time Aging, followed by required ISO 11607 Integrity Testing such as Bubble Leak Testing per ASTM F2096, Peel Strength Testing per ASTM F88, and more. We are here to continue being a resource for our clients through this unprecedented time.
If you have any questions about your device’s validation, please feel free to reach out to PCL. To inquire about an EAU for your device, please call the FDA Coronavirus COVID-19 Hotline at 1-888-INFO-FDA, and choose option ‘*’.