Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans Can an IVD device qualify for HUD designation if the affected patient population is fewer than 4,000 per year but each patient may need to be tested multiple times? 1.51K viewsFDA 0 Votes 1 Ans Is there a regulation that specifically addresses labeling of IVD products? 1.59K viewsFDA 0 Votes 1 Ans Are there different goals for IVD studies compared to other device studies? 1.67K viewsFDA 0 Votes 1 Ans What regulations describe the content requirements for IVD premarket submissions? 1.71K viewsFDA 0 Votes 1 Ans Can published literature be used to support an IVD premarket submission? 1.33K viewsFDA 0 Votes 1 Ans Can data from studies performed outside of the United States (U.S.) be used to support an IVD premarket submission? 1.27K viewsFDA 0 Votes 1 Ans Can foreign/international data be used as the sole support of a marketing application? 1.28K viewsFDA 0 Votes 1 Ans When and how should a waiver request be submitted? 1.45K viewsFDA 0 Votes 1 Ans Should a sponsor or applicant expect a response to a waiver request? 1.66K viewsFDA 0 Votes 1 Ans What if the sponsor or applicant does not hear back from FDA regarding a waiver request? 1.63K viewsFDA 0 Votes 1 Ans Under what circumstances would a waiver be granted? 1.64K viewsFDA 0 Votes 1 Ans How long must a sponsor or applicant retain records required under 21 CFR 312.120? 1.44K viewsFDA 0 Votes 1 Ans What is the purpose of this guidance document and how does it differ from other guidance documents related to IVD products? 1.51K viewsFDA 0 Votes 1 Ans Why are in vitro diagnostics considered devices? 1.52K viewsFDA 0 Votes 1 Ans How do IVD devices differ from other devices? 1.59K viewsFDA 0 Votes 1 Ans Which Divisions at FDA are responsible for review of IVD products? 1.53K viewsFDA 0 Votes 1 Ans Which regulations contain provisions relevant to the IVD industry? 1.65K viewsFDA 0 Votes 1 Ans How do I determine the applicability of the IDE regulation to my IVD study? 1.39K viewsFDA 0 Votes 1 Ans How do I determine if the study is a significant or non-significant risk study under 21 CFR 812.2(b)? 1.53K viewsFDA 0 Votes 1 Ans How do I determine if an invasive sampling technique presents a significant risk under 21 CFR 812.2(c)(3)? 1.30K viewsFDA « Previous 1 2 … 145 146 147 148 149 … 283 284 Next » Question and answer is powered by anspress.net
