The agency issued a proposed rule addressing tobacco regulation last month that also includes amendments regarding "intended uses" of devices and drugs. It could offer an opportunity for companies to get more clarity from FDA on off-label promotion issues. But one attorney says it's frustrating that FDA neglected to incorporate any recent feedback from the courts that its enforcement of off-label marketing runs afoul of the First Amendment.
FDA put out a proposed rule
targeting tobacco products last month that should not be ignored by device and drug manufacturers, attorneys say.
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
Simultaneous revisions of the EU’s AI, data and medtech rules offer opportunities for simplification and alignment but also risk confusion and competing priorities. With political tensions in the background, does all this portend further unwanted compromises or delays for medtech?
After years of delays - and even skepticism in Rome last month when officials hinted at its imminent debut - the long-awaited EUDAMED medical device database release has finally been confirmed
The European Commission’s Digital Omnibus Package promises to simplify EU complex digital compliance processes, but is it taking the EU in the right direction in its simplification efforts?
Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.
Abbott has initiated a medical device correction for about 3 million FreeStyle Libre 3 and FreeStyle Libre 3 Plus sensors in the US after internal testing detected a risk the device may produce inaccurate glucose readings.
A recent study demonstrates that certain types of blood-based tests that screen for multiple cancers at once have the potential to flip the script on cancer diagnoses, including some of the deadliest types.
The European Commission seems to have heeded many of the medtech industry’s points regarding challenges with the implementation of the AI Act within the Digital Omnibus. But the usual EU hurdles must be crossed before the sector will know if these proposals will make it into law.
