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? 1.89K 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? 1.76K viewsFDA 0 Votes 1 Ans Is it appropriate to use a quality systems approach in the conduct of IVD studies? 1.79K 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? 1.55K viewsFDA 0 Votes 1 Ans When does an IVD study involve human subjects? 1.93K 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? 1.40K viewsFDA 0 Votes 1 Ans What regulations apply regarding human subject protection in investigational IVD studies? 1.65K viewsFDA 0 Votes 1 Ans What does noninvasive mean? 1.83K viewsFDA 0 Votes 1 Ans What does it mean to have “confirmation of the diagnosis by another, medically established diagnostic product or procedure?” 1.84K viewsFDA 0 Votes 1 Ans What if no medically established means for diagnosing the disease or condition exists? 1.83K viewsFDA 0 Votes 1 Ans Can an investigational IVD device be used outside of the study protocol, in an emergency situation? 1.73K 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? 1.73K viewsFDA 0 Votes 1 Ans Are treatment IDEs and continued access available for investigational IVDs under an IDE? 1.56K 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)? 1.50K 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? 1.65K viewsFDA 0 Votes 1 Ans Is there a regulation that specifically addresses labeling of IVD products? 1.73K viewsFDA 0 Votes 1 Ans Are there different goals for IVD studies compared to other device studies? 1.80K viewsFDA 0 Votes 1 Ans What regulations describe the content requirements for IVD premarket submissions? 1.93K viewsFDA 0 Votes 1 Ans Can published literature be used to support an IVD premarket submission? 1.46K 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? 1.43K viewsFDA « Previous 1 2 … 9 10 11 12 13 … 75 76 Next » Question and answer is powered by anspress.net
