Regulatory
Lessons learned
Emergency Use Authorisations (EUAs) have seemingly been given left, right and centre by the FDA during the Covid-19 pandemic. The regulator has been praised for how quickly it moved to ensure the volume of mechanical ventilators, IVDs and PPE was adequate – but does the efficiency of the EUA process raise questions about how regulation operates outside of emergencies? Peter Littlejohns asks Kim Trautman, vice-chair of the Industry and Professional Advisory Council at Penn State University College of Engineering, and Dr Jeffrey Shuren, director of the Center for Devices and Radiological Health at the FDA, what regulators have learned from the pandemic.
A
regulatory office doesn’t often conjure up images of speed and efficiency. After all, it’s not usually the rule makers that have to innovate. But when the Covid-19 pandemic led to increased demand for the devices that help treat, protect against and test for the SARS-CoV-2 virus, the FDA rose to the challenge and softened the requirements for using certain technologies in the field. What a lot of people won’t know, however, is that many of the provisions that allowed for this were drafted all the way back in the mid-1990s. “Regulations don’t change fast, which is why back in 1996 we added some provisions to allow for something like this,” says Kim Trautman, former
Medical Device Developments /
www.nsmedicaldevices.com
associate director of international affairs at the FDA Center for Devices and Radiological Health (CDRH).“We put in provisions so that under emergency circumstances, the agency would be able to waive certain aspects of the quality systems regulation.” Trautman knows these provisions better than anyone – she wrote them. During Trautman’s 24-year stint at the FDA, the US Congress also signed the Project Bioshield Act of 2004, which expanded on her provisions and gave the FDA further authority to relax regulation by introducing the Emergency Use Authorisation (EUA) programme. Prior to the current pandemic, the new legislation was used in response to outbreaks of SARS, MERS, Ebola
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