An updated 510(k) “refuse to accept” guidance document gives FDA staff more opportunity to work with sponsors to smooth out product submissions without repeatedly halting and restarting the review clock with RTA determinations.
FDA's updated
guidance on its 510(k) “refuse to accept” (RTA) policy gives agency staff more liberty to decide what elements of...
Join thousands of industry professionals who rely on Medtech Insight for daily insights
Already a subscriber?
Healthcare product industries await publication of the NHS 10-Year Plan, due out the coming days, which will focus on health generally not just the NHS, UK health secretary Wes Streeting said during a final prelaunch event on 24 June.
From June 30, new European Commission rules will attempt to redress an imbalance in medtech trade between the EU and the People’s Republic of China.
Legal experts warn, however, that new Mexican procurement rules are discriminatory and could be challenged in the courts.
