In an exclusive sit-down with Medtech Insight, CDRH Director Jeff Shuren talked about his priorities for his center over the next three years and how they could impact the medical device industry. The overall aim is to boost the number of novel medical devices that reach the US market first.
Jeff Shuren, director of US FDA's Center for Devices and Radiological Health, says a new set of strategic priorities listed by the device center are part of its efforts to make major changes to the device regulatory process with the aim off helping to get more novel medical devices to come to the US market first.
CDRH released its strategic priorities covering 2018 through 2020. Included are efforts to improve employee engagement, streamlining the center's...
Despite staffing cuts and uncertainty at the FDA, the US still offers EU medtech firms stronger regulatory support, regulatory expert Bassil Akra told Medtech Insight. This is especially valued as EU rules are often viewed as overly stringent, unclear and difficult to follow.
The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.
EU4Health, the main funding instrument for EU health initiatives, has put renewed emphasis on orphan devices in its 2025 work program, published in July.
The US FDA has authorized around 107 devices with Predetermined Change Control Plans in place, with PathAI's AISight Dx digital pathology image management system one of the latest. Medtech Insight talks to Eric Walk, chief medical officer, to find out about the process and its benefits.
Hopes that last-minute negotiations might exempt Brazil’s $300m medtech exports from the latest round of US tariffs have been dashed, leaving the industry braced for further market instability that countermeasures could trigger.
Medical device firms often have serious compliance gaps, a recent Veeva MedTech survey found. Only 50% of the companies surveyed are confident in their global registration data, with 70% reporting inconsistencies during audits. The report recommends automation and better data governance.
The US FDA says PFAS used in medical devices are safe and that there’s no reason to restrict them in device production. An environmental group finds the agency’s assertion questionable.
