FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 0 Votes 1 Ans Can foreign/international data be used as the sole support of a marketing application? 1.27K 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? 1.51K 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? 1.52K viewsFDA 0 Votes 1 Ans Which regulations contain provisions relevant to the IVD industry? 1.64K 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)? 1.52K 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 0 Votes 1 Ans Would a study report “Synopsis” (as shown in ICH E3, Annex I)26 provide a sufficiently detailed summary of the protocol and study results? 1.68K viewsFDA 0 Votes 1 Ans Will FDA need access to case records maintained by the investigator or additional background data such as hospital or other institutional records? 1.64K viewsFDA 0 Votes 1 Ans What information should the sponsor or applicant provide to meet the requirement in 21 CFR 312.120(b)(4)? 1.38K viewsFDA 0 Votes 1 Ans What information should the sponsor or applicant submit to FDA to show that the study is adequate and well controlled under 21 CFR 314.126? 1.70K viewsFDA 0 Votes 1 Ans What does FDA consider an “adequately constituted” IEC? 1.54K viewsFDA 0 Votes 1 Ans What information must the sponsor or applicant provide to FDA and what information must the sponsor or applicant maintain with respect to the names and qualifications of all IEC members? 1.73K viewsFDA « Previous 1 2 … 10 11 12 13 14 … 75 76 Next » Question and answer is powered by anspress.net
