We use cookies to provide you with a better experience. By continuing to browse the site you are agreeing to our use of cookies in accordance with our Cookie Policy.
Ireland’s national standards organization and notified body is advising devicemakers to become certified to global standards to get ahead of uncertainty surrounding Brexit. Read More
Brazil’s National Agency for Sanitary Vigilance is seeking industry comments on a proposal that would extend licenses for medical devices from five years to 10 years. Read More
The FDA’s Patient Engagement Advisory Committee (PEAC) will hold its inaugural meeting in Gaithersburg, Maryland, October 11-12 to discuss how patients, devicemakers, and the FDA can share information. Read More
As one of its final items before leaving for the summer, the Senate overwhelmingly voted to reauthorize the FDA’s user fee agreements through fiscal 2022, completing over two years of work. Read More
The FDA finalized its list of 1,003 class II medical devices low-risk enough to be exempt from 510(k) requirements, but stressed that all devices, exempt or otherwise, are subject to current device GMPs, packaging and labeling rules, and regulations on intended use. Read More