Regulatory agencies from around the world are fast-tracking regulatory approvals for medical devices, but what happens when emergency use authorizations (EUAs) end?
The COVID-19 pandemic has thrown everything we consider “normal” into a tailspin. Supply chains are stretched thin, workforces reduced and storefronts shuttered. But, even as the economy contracts, medical device manufacturers and research groups are stepping up to fill supply chain gaps and develop solutions—in vitro, respiratory, pharmaceutical and so forth—to combat COVID-19.
Regulatory agencies from around the world are fast-tracking regulatory approval for medical devices and healthcare products to bring new therapies to patients as quickly as possible while evaluating whether these new products or use cases are safe and effective. Balancing the two needs—speed-to-market and safety—has become more critical than ever with public-private partnerships paving the path for practical solutions.
The rapidly evolving conditions call for exceptional support to meet not only current demand but to also plan for the long haul as medical professionals predict a protracted response—the novel coronavirus isn’t going away anytime soon. While regulatory approaches are shifting quickly, approvals issued under emergency use authorizations (EUAs) will end once the public health emergency is over.
Planning for the eventual termination of the EUA, even though it may be far in the future, should be considered when pivoting resources and adapting manufacturing processes to fill medical equipment shortages.
One way to prepare for the eventual end of EUAs is to pursue premarket submissions through the appropriate regulatory pathway. UL offers a comprehensive suite of new and altered medical device and product services that span the entire production cycle.
From performing early-stage reviews to clarify applicable safety standards and regulatory requirements to global market access services, we offer accelerated and virtual support to help manufacturers successfully and safely address supply shortages.
We know that collaboration is increasingly important for innovation, as demonstrated by UL’s 2019 Innovation and Safety study. Survey respondents from across multiple industries overwhelmingly agreed that regular collaboration with organizations gives companies a competitive advantage (72%) in the marketplace.
Now more than ever, this global health crisis requires close collaboration with all stakeholders—industry, regulators, public organizations and companies like UL. We all have an essential role to play in COVID-19 response and recovery; we welcome the opportunity to support your efforts in responding to crises, reopening business and recovering in our new normal.
New emergency-use provisions in the U.S., Europe and other regions are allowing manufacturers of ventilators, personal protective equipment (PPE) and other products expedited market access; but quality, safety and performance requirements must still be met.
We now offer accelerated and virtual options for many of our routine healthcare product testing and inspection services to help manufacturers successfully and safely address supply shortages. Our experience enables us to streamline the go-to-market process for re-engineered products that include new features or health benefits to meet emerging needs stemming from the pandemic.
Our comprehensive service offerings span the entire production cycle, with early-stage reviews to clarify applicable safety standards and regulatory requirements, performance and safety testing, product certification and global market access services.