Regulatory


agency has what it needs to recover its operations and get back on track.” It stands to reason that Weems and the manufacturers of medical imaging equipment and software he represents would want to see the FDA get back on its feet; after all, a well-resourced FDA means shorter review times – theoretically at least. The reason this could be difficult to achieve in practice is that the agency has historically struggled to retain, let alone recruit staff and this situation was exacerbated as the Emergency Use Authorisation (EUA) programme led to an influx of submissions, mostly from IVD manufacturers, which tested the resolve of employees to stay in their jobs and risk burnout. In the summer of 2021, a slowdown in approvals occurred, and Dr Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health (CDRH) gave an impassioned speech about the agency’s lack of funding at a briefing sponsored by the Alliance for a Stronger FDA. In the speech, which was reported by MedPage Today, he said: “Many in the public, some in industry, some elsewhere, are just used to us being underfunded and somehow always pulling off a miracle. I will tell you that after having gone through the pandemic and where we are, there are essentially no more rabbits to pull from our hat. That’s the bottom line.”


Speed to market During the negotiations with industry groups, which included MITA, as well as other advocates like AdvaMed and Medical Device Manufacturers Association (MDMA), it became clear that the CDRH had spent its congressional appropriation funding – the main source of its income – instead of the roughly 35% of its financial resources that comes from user fees, on staffing and other costs associated with the review and approval of devices. It did this to build up a reserve of carryover user fee funding to be ringfenced for updating its IT capabilities and bringing much of its activity onto the cloud – an ambition, it believes, would result in more efficient reviewing. “FDA had accrued a very significant carryover balance,” says Weems.


Medical Device Developments / www.nsmedicaldevices.com


“During the pandemic there have been resource challenges for the FDA and as we move beyond and hopefully find ourselves at the tail end, we want to make sure the agency has what it needs to recover its operations and get back on track.”


“That’s money that we want to be invested in the programme, because we all need it to be properly resourced and staffed.” This was the opinion echoed by the industry groups at large, especially given that MDUFA V represents a significant uptick


Digitalization from Shop Floor to Top Floor


Quality Management Software www.CAQ.de


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