Device Reg Issues In Play As FDA Kicks Off User Fee Renewal Effort
FDA will host a public meeting July 13 to hear public input in advance of agency-industry negotiations to reauthorize the device user-fee program. Industry appears to feel better about the device-review program than it did during the prior user-fee program, but what the top issues will be during negotiations this time around remain to be seen. Ongoing reform efforts in Congress will impact the process.
FDA will officially kick off the device user fee reauthorization process July 13 with a public meeting at its Silver Spring, Md., headquarters.
Leading up to the meeting, industry representatives appear to be more satisfied with the current device-review program compared to the...
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.
The Centers for Medicare and Medicaid Services has launched a new program the agency says will allow patients easier access to their health data. More than 60 companies have already signed on.
The FTC is suing to block Edwards Lifesciences' purchase of JenaValve, citing concerns that it would reduce competition and innovation in the heart valve market and negatively impact patient access to vital treatments for aortic regurgitation. Edwards disagrees with the decision.
In return for building a successful US export business, Switzerland has been handed a 39% tariff effective immediately by the Trump administration. Diplomatic channels have been reopened to undo the tariff. Meanwhile, the medtech industry is looking to develop OUS markets for Swiss exporters.
The US FDA issued a pair of early alerts on Wednesday warning customers about serious adverse events associated with two Boston Scientific cardiac devices. Both alerts include numerous reports of injuries and deaths and are part of the FDA’s ongoing pilot to enhance its recall process.