Regulatory
“For a company, strategically it was great, because they could get a CE mark with less evidence, put [their product] into the market and use real-world data to capture the rest of the evidence and package it up to bring to the FDA,” says Trautman. “Dr Shuren and several senior leaders continually got beat up by Congress, who were saying ‘innovative devices are going outside the US to Europe before they’re coming here – what the heck is the issue?’”
Prior to the Covid-19 pandemic, EUAs were most notably used during the swine fl u pandemic, when 22 were granted.
The challenge that comes with this fluid interaction is that it’s very resource intensive for the FDA, and for that reason, Shuren has proposed that it be implemented for products designated as Breakthrough Devices, as well as within its Safer Technologies Program (STeP) for medical devices. These schemes are geared toward introducing technology for an unmet need or improving the safety of a current treatment pathway, which Shuren says makes them ideal candidates for the extra attention.
“Europe handed the US a gift. Now, it’s more advantageous to bring products to the US market fi rst.”
Kim Trautman
The swinging pendulum Shuren’s desire for a more flexible regulatory system isn’t just a result of Covid-19, he’s been arguing for it within the industry and in regulatory circles for several years. The context in which this matters, however, isn’t just the need for greater patient access to innovative new devices; the US also wants to be competitive in the international marketplace. Shuren notes in a recent article for the Regulatory Affairs Professional Society (RAPS) that when he became director of CDRH in 2009, devices were being approved overseas before they came to the US due to increasing review times and a lack of predictability and transparency in the FDA’s pre-market review process. Trautman was working at the FDA when Shuren took the reins at the CDRH, and she also remembers this being the case, adding that much of his career since has been focused on shortening the time to approval for devices while maintaining FDA standards.
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In response, Shuren would point to the fact that the CE mark didn’t actually put devices into physician’s or patient’s hands, and that they had to go through a reimbursement approval process in each EU member state before they could have any real benefit. Trautman recalls him referencing cases in which the lack of clinical evidence required for a CE mark resulted in “significant problems” with the devices – which most notably happened with the PIP breast implant scandal. Tellingly, this 20-year timeline of failures, along with other notable cases, contributed to the EU’s decision to dramatically tighten regulation in the form of the European Medical Devices Regulation (MDR) and In Vitro Diagnostic Devices Regulation (IVDR). While much of Shuren’s career has been focused on trying to ‘swing the pendulum’ by making it a more attractive proposition for companies to vet their products in the US first, Trautman says “Europe handed the US a gift” by creating the MDR and IVDR. “Now, it’s more advantageous to bring products to the US market first,” she adds.
Changes to come? In future, Trautman believes the EU will need to balance the tough restrictions put in place by the MDR and IVDR, so that the pendulum that’s currently swinging towards the FDA reaches a point of greater equilibrium – but she says this will probably take between five and ten years. In the meantime, Shuren continues to push for greater flexibility to tailor device approval requirements across the FDA’s numerous pathways, so that they better fit the technology of today. The experience of Covid-19, he believes, could help him convince Congress to make the necessary legal adjustments. “These kinds of ideas take time to settle in the minds of folks, but Covid has helped,” he says. “As big opportunities come up to make changes to US federal law as it applies to the FDA, these kinds of issues come to the fore.” Next year, the legislation that allows the FDA to collect user fees – a revenue stream that provides nearly half of its $6bn budget – expires and will require reauthorisation. It’s at this time Shuren hopes to gain the political allies needed to make his regulatory vision a reality. ●
Medical Device Developments /
www.nsmedicaldevices.com
Dusan Petkovic/
Shutterstock.com
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