FDA FDA 1501 Questions Ask question Search Order By: ActiveClear Filter 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? 1.78K 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? 1.65K viewsFDA 0 Votes 1 Ans Is it appropriate to use a quality systems approach in the conduct of IVD studies? 1.66K 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? 1.43K viewsFDA 0 Votes 1 Ans When does an IVD study involve human subjects? 1.71K 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? 1.29K viewsFDA 0 Votes 1 Ans What regulations apply regarding human subject protection in investigational IVD studies? 1.52K viewsFDA 0 Votes 1 Ans What does noninvasive mean? 1.73K viewsFDA 0 Votes 1 Ans What does it mean to have “confirmation of the diagnosis by another, medically established diagnostic product or procedure?” 1.73K viewsFDA 0 Votes 1 Ans What if no medically established means for diagnosing the disease or condition exists? 1.72K viewsFDA 0 Votes 1 Ans Can an investigational IVD device be used outside of the study protocol, in an emergency situation? 1.62K 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? 1.61K viewsFDA 0 Votes 1 Ans Are treatment IDEs and continued access available for investigational IVDs under an IDE? 1.42K 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)? 1.38K viewsFDA 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? 1.54K viewsFDA 0 Votes 1 Ans Is there a regulation that specifically addresses labeling of IVD products? 1.63K viewsFDA 0 Votes 1 Ans Are there different goals for IVD studies compared to other device studies? 1.70K 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 « Previous 1 2 … 9 10 11 12 13 … 75 76 Next » Question and answer is powered by anspress.net
