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? 1.62K viewsFDA 0 Votes 1 Ans Is there a regulation that specifically addresses labeling of IVD products? 1.72K viewsFDA 0 Votes 1 Ans Are there different goals for IVD studies compared to other device studies? 1.78K viewsFDA 0 Votes 1 Ans What regulations describe the content requirements for IVD premarket submissions? 1.90K viewsFDA 0 Votes 1 Ans Can published literature be used to support an IVD premarket submission? 1.44K 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? 1.41K viewsFDA 0 Votes 1 Ans Can foreign/international data be used as the sole support of a marketing application? 1.41K viewsFDA 0 Votes 1 Ans When and how should a waiver request be submitted? 1.64K viewsFDA 0 Votes 1 Ans Should a sponsor or applicant expect a response to a waiver request? 1.76K viewsFDA 0 Votes 1 Ans What if the sponsor or applicant does not hear back from FDA regarding a waiver request? 1.75K viewsFDA 0 Votes 1 Ans Under what circumstances would a waiver be granted? 1.75K viewsFDA 0 Votes 1 Ans How long must a sponsor or applicant retain records required under 21 CFR 312.120? 1.55K 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? 1.63K viewsFDA 0 Votes 1 Ans Why are in vitro diagnostics considered devices? 1.65K viewsFDA 0 Votes 1 Ans How do IVD devices differ from other devices? 1.70K viewsFDA 0 Votes 1 Ans Which Divisions at FDA are responsible for review of IVD products? 1.74K viewsFDA 0 Votes 1 Ans Which regulations contain provisions relevant to the IVD industry? 1.89K viewsFDA 0 Votes 1 Ans How do I determine the applicability of the IDE regulation to my IVD study? 1.51K 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)? 1.64K 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)? 1.41K viewsFDA « Previous 1 2 … 145 146 147 148 149 … 283 284 Next » Question and answer is powered by anspress.net
