Regulatory


emergency, but not in a non-emergency setting.” But while regulatory requirements may not change, given the right political support, exactly how they’re met could. “The EUA authorities allow tremendous flexibility in crafting what it takes to meet [the requirements], and to adapt much more quickly,” says Shuren. “In non-emergency settings, the pathways to demonstrate that standard… have much more prescriptive requirements that may not be appropriate for particular technologies.” One example he gives is products that fall under the category of Software as a Medical Device (SaMD). These products, he says, have much shorter innovation cycles than the hardware for which the current regulatory framework was designed. “Having the kind of flexibility we have with the EUA authorities would allow us to craft those pathways to better fit the technology and its innovation cycle, while still having in place appropriate patient safeguards.” Ultimately, he believes this would better drive innovation in medical technology – but it would also require a change in US law.


Virtual review


Another lesson learned from the Covid- 19 emergency was linked to the inability of manufacturers to travel. Prior to the pandemic, pre-submission meetings were held by the FDA to allow companies to come and get opinions on the technical aspects of their devices. “Literally, people would come to Rockville, Maryland, to FDA’s campus,” says Trautman. “It costs a lot of money for people, wherever they are on the globe, to pack up their executives and technical team and march them down.” What’s more, if manufacturers had further questions that needed addressing, they had to request another meeting and make a second schlep to Rockville. With the restrictions imposed by Covid-19, the agency pivoted to a more direct approach to interacting with manufacturers, using video conferencing tools to conduct presubmission meetings and other requests for input from the FDA’s experts. “There are two means of communication in particular that I want to highlight,” says Shuren. “The first being our holding of a weekly webinar for [IVD] developers, which started the first week of March 2020. This has been very


Medical Device Developments / www.nsmedicaldevices.com


helpful in conveying information and answering questions. It’s very resource intensive, but under the circumstances it provided value to all parties.” The second, he adds, is the agency’s pre-EUA programme, which allowed developers to request ‘very fluid interactions’ with experts at CDRH. The result, at least in the IVD space, was the reduction of a process that usually takes months to a matter of weeks. “This kind of engagement, combined with the flexibility of the EUA standard, was absolutely critical in facilitating the more rapid development of validation and authorisation of medical devices during Covid-19. I would like to see that level of engagement occur in non-emergency situations.”


420


Tests and sample collection devices authorised by the FDA under the EUA programme. FDA


Software Solutions for the World of Medical Devices


Innovation in the Name of Quality www.CAQ.de


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