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? 1.55K viewsFDA 0 Votes 1 Ans Is there a regulation that specifically addresses labeling of IVD products? 1.64K viewsFDA 0 Votes 1 Ans Are there different goals for IVD studies compared to other device studies? 1.71K viewsFDA 0 Votes 1 Ans What regulations describe the content requirements for IVD premarket submissions? 1.78K viewsFDA 0 Votes 1 Ans Can published literature be used to support an IVD premarket submission? 1.36K 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? 1.30K viewsFDA 0 Votes 1 Ans Can foreign/international data be used as the sole support of a marketing application? 1.32K viewsFDA 0 Votes 1 Ans When and how should a waiver request be submitted? 1.52K viewsFDA 0 Votes 1 Ans Should a sponsor or applicant expect a response to a waiver request? 1.70K viewsFDA 0 Votes 1 Ans What if the sponsor or applicant does not hear back from FDA regarding a waiver request? 1.68K viewsFDA 0 Votes 1 Ans Under what circumstances would a waiver be granted? 1.68K viewsFDA 0 Votes 1 Ans How long must a sponsor or applicant retain records required under 21 CFR 312.120? 1.48K 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? 1.56K viewsFDA 0 Votes 1 Ans Why are in vitro diagnostics considered devices? 1.57K viewsFDA 0 Votes 1 Ans How do IVD devices differ from other devices? 1.63K viewsFDA 0 Votes 1 Ans Which Divisions at FDA are responsible for review of IVD products? 1.59K viewsFDA 0 Votes 1 Ans Which regulations contain provisions relevant to the IVD industry? 1.71K viewsFDA 0 Votes 1 Ans How do I determine the applicability of the IDE regulation to my IVD study? 1.43K 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)? 1.57K 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)? 1.34K viewsFDA « Previous 1 2 … 145 146 147 148 149 … 283 284 Next » Question and answer is powered by anspress.net
