Regulatory
of devices get to learn from TAP advisors and their own product stakeholders how best to adapt devices for the most effective product-market fit. Only products designated Breakthrough Devices will be included until 2025, at which point the agency will consider those with a request for inclusion in the Safer Technologies Program (STeP) –a pathway for accelerated approval on the basis that a device improves the safety of a current treatment. “The TAP programme will scale up over the next five years and create new opportunities for enhanced early communication, collaboration and engagement between the agency and innovative medical device manufacturers,” says Weems. “We’re always interested in collaborating with the agency to test out new regulatory pathways and models that support access to safe and effective medical devices and we’ve seen the Breakthrough Devices programme as a cornerstone of that.”
Mutual ambitions
Outside of the discussion around fees and pathway improvements, a mutual long-term ambition of CDRH and of the industry groups involved in the discussions has been preparing for the arrival of devices and Software as a Medical Device products that have AI capabilities at their core. “For us, digital health in medical imaging is a huge priority, including advances in AI and machine learning technologies,” says Weems. MITA develops standards for medical imaging products, both in-house under the auspices of parent company the National Electrical Manufacturers Association (NEMA) and in collaboration with international standards development organisations, such as the International Electrotechnical Commission (IEC) and the International Organisation
Medical Device Developments /
www.nsmedicaldevices.com
for Standardisation (ISO). For this reason, Weems adds that “ongoing investment in the use of standards for pre-market regulatory decisions was a priority [for MITA]”. Another shared priority Weems identifies is “continuing the drive towards the harmonisation of international medical device regulatory activities”. “Ongoing investment in that under MDUFA V is something we’re very glad to see.”
Despite the back and forth with the FDA over its spending plans, Weems believes MDUFA V is a good deal for the industry and that will become evident between now and 2027. “Over the last several years, our member companies have introduced a number of innovative technologies to market,” he says. “Things like low-dose CT scans, high tesla MRIs, advanced ultrasound applications and some AI and machine learning algorithms. We’ve had good success bringing these technologies to market under the user fee programme. In the next five years under MDUFA V we’ll see a lot more exciting innovation.” ●
Above: The FDA must recruit 144 new staff in 2023 or risk losing some of its medical device review funding through discounting registration fees.
Below: The risk of employee burnout at CDRH has been significant during the pandemic, as review submissions piled up for IVDs.
$1.7bn
The amount the FDA is guaranteed in user fees over the next five years, but this number could rise to $1.9bn if it meets certain objectives
FDA
19
Rawpixel.com; wutzkohphoto/
Shutterstock.com
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