Regulatory


and Zika, but most notably during the H1N1 pandemic also known as ‘swine flu’, when 22 EUAs were granted. Yet, the number of emergency authorisations given in the 16 years prior to Covid- 19’s arrival in the US seems tiny now. As of today, 420 tests and sample collection devices are currently authorised by the FDA under the EUA programme, according to the latest update from the regulator. If the EUA programme was part of a scientific study, then Covid-19 gave it the largest amount of sample data so far, and much like a study, the experience has taught the FDA lessons that could result in changes to non-emergency regulatory practice.


“Having the kind of fl exibility we have with the EUA authorities would allow us to craft those pathways to better fi t the technology and its innovation cycle, while still having in place appropriate patient safeguards.”


Jeffrey Shuren


Tailored requirements To understand the insights gleaned from the EUA programme during the pandemic, it’s important to grasp how it operates. “The EUA standard is


different from the standard during peace time, if you will,” says Dr Jeffrey Shuren, director of the Center for Devices and Radiological Health (CDRH) at the FDA. “The EUA standard is that a device ‘may’ be effective, so it’s a lower bar that balances having at least some confidence a medical product works, while also expediting access to it.” In practice, this means the amount of data manufacturers are required to show the regulator before they are able to take a product to market is far less than it would be under normal circumstances – so long as they can provide adequate safety data. The agreement on the part of the companies is that they continue to collect both safety and efficacy data from the use of their product and report this to the FDA, so that devices that prove unsafe or ineffective can be quickly removed from the market. With the EUA programme so rapidly and widely administered, some have voiced concerns that a precedent might be set that pressures the FDA to continue the relaxed requirements long after the pandemic. But Shuren says the standard of a “reasonable assurance of safety and effectiveness” will not change for non-EUA applications. “It would not be the EUA standard that [a product] may be effective. That’s a lower bar that’s appropriate in an


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Medical Device Developments / www.nsmedicaldevices.com


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