RE: FDA/MEDICAL DEVICES20 Aug 2020 09:04
FDA have a deadline to respond to the application for a deNovo device it is 180days so that's 6months. Every time the FDA asks a question the clock stops and is restarted once answered. AGL have done their best to avoid any further questions and subsequent clock stopping by previously making an FDA "Q" submission which gave the FDA the opportunity to ask questions before the final application is submitted. It was that submission that generated the extra analytical work in January which required more volunteer blood samples and that they are completing now. On that basis there should not be any "new" questions, but new FDA members like the sound of their own voice and as far as USA is concerned anything goes so there are no guarantees.