Questions Ask question Search Order By: ActiveCategoryClear Filter 0 Votes 1 Ans How do I arrange to reference a MAF? 1.49K viewsFDA 0 Votes 1 Ans What does FDA consider to be valid scientific evidence? 1.39K viewsFDA 0 Votes 1 Ans Why should I review the information regarding the conduct of device studies found in the IDE regulation even if, after considering the exemption criteria in the regulation, I determine that my proposed studies are exempt from most IDE requirements? 1.47K viewsFDA 0 Votes 1 Ans Should I review the “International Conference on Harmonization; Good Clinical Practice: Consolidated Guideline” (“”ICHGCP””) published in the Federal Register Vol. 62, No. 90, May 9, 1997, pp. 25691-25709 or the draft ISO 14155, “Clinical Investigation of Medical Devices for Human Subjects,” when developing studies for devices that fall within the exemption at 21 CFR 812.2(c)? 1.63K viewsFDA 0 Votes 1 Ans Is FDA willing to review and discuss a study protocol even if the study is exempt from most of the 21 CFR Part 812 requirements? 1.65K viewsFDA 0 Votes 1 Ans Can I obtain a more formal evaluation of my study design or investigational plan through a determination and/or agreement meeting? 1.64K viewsFDA 0 Votes 1 Ans Under 21 CFR Part 812, what are the sponsor’s and investigator’s responsibilities for studies of a non-significant risk device conducted under the abbreviated requirements in 21 CFR Part 812? 1.74K viewsFDA 0 Votes 1 Ans What are my responsibilities as the sponsor or the investigator of a study of a significant risk device subject to 21 CFR Part 812? 1.61K viewsFDA 0 Votes 1 Ans Is it appropriate to use a quality systems approach in the conduct of IVD studies? 1.62K viewsFDA 0 Votes 1 Ans If a sponsor’s ‘in-house’ laboratory participates in the study of an IVD is the laboratory considered to be a study site? 1.39K viewsFDA 0 Votes 1 Ans When does an IVD study involve human subjects? 1.65K viewsFDA 0 Votes 1 Ans Am I required to follow the “Good Laboratory Practice for Nonclinical Studies” regulation (21 CFR Part 58) in my IVD study? 1.25K viewsFDA 0 Votes 1 Ans What regulations apply regarding human subject protection in investigational IVD studies? 1.47K viewsFDA 0 Votes 1 Ans What does noninvasive mean? 1.68K viewsFDA 0 Votes 1 Ans What does it mean to have “confirmation of the diagnosis by another, medically established diagnostic product or procedure?” 1.67K viewsFDA 0 Votes 1 Ans What if no medically established means for diagnosing the disease or condition exists? 1.65K viewsFDA 0 Votes 1 Ans Can an investigational IVD device be used outside of the study protocol, in an emergency situation? 1.58K viewsFDA 0 Votes 1 Ans Can an unapproved or uncleared investigational IVD device ever be used for nonemergency treatment of patients who do not meet the inclusion criteria of an investigational study? 1.57K viewsFDA 0 Votes 1 Ans Are treatment IDEs and continued access available for investigational IVDs under an IDE? 1.37K viewsFDA 0 Votes 1 Ans Can my IVD device be considered a humanitarian use device (HUD) and can I apply for marketing approval through a humanitarian device exemption (HDE)? 1.34K viewsFDA « Previous 1 2 … 144 145 146 147 148 … 283 284 Next » Question and answer is powered by anspress.net
