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? 1.69K viewsFDA 0 Votes 1 Ans Is there a regulation that specifically addresses labeling of IVD products? 1.79K viewsFDA 0 Votes 1 Ans Are there different goals for IVD studies compared to other device studies? 1.85K viewsFDA 0 Votes 1 Ans What regulations describe the content requirements for IVD premarket submissions? 1.99K viewsFDA 0 Votes 1 Ans Can published literature be used to support an IVD premarket submission? 1.50K 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? 1.48K viewsFDA 0 Votes 1 Ans Can foreign/international data be used as the sole support of a marketing application? 1.48K viewsFDA 0 Votes 1 Ans When and how should a waiver request be submitted? 1.76K viewsFDA 0 Votes 1 Ans Should a sponsor or applicant expect a response to a waiver request? 1.83K viewsFDA 0 Votes 1 Ans What if the sponsor or applicant does not hear back from FDA regarding a waiver request? 1.81K viewsFDA 0 Votes 1 Ans Under what circumstances would a waiver be granted? 1.83K viewsFDA 0 Votes 1 Ans How long must a sponsor or applicant retain records required under 21 CFR 312.120? 1.61K 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? 1.71K viewsFDA 0 Votes 1 Ans Why are in vitro diagnostics considered devices? 1.72K viewsFDA 0 Votes 1 Ans How do IVD devices differ from other devices? 1.76K viewsFDA 0 Votes 1 Ans Which Divisions at FDA are responsible for review of IVD products? 1.85K viewsFDA 0 Votes 1 Ans Which regulations contain provisions relevant to the IVD industry? 2.04K viewsFDA 0 Votes 1 Ans How do I determine the applicability of the IDE regulation to my IVD study? 1.59K 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)? 1.72K 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)? 1.48K viewsFDA « Previous 1 2 … 145 146 147 148 149 … 283 284 Next » Question and answer is powered by anspress.net
