Translational Pathways for Cardiovascular Devices – Session IV: Current Challenges and Future Direction for Coronary Stent Development and Iteration – FDA Point of Review – Michael John Practice Quiz

The FDA premarket application for a coronary drug-eluting stent requires?

The FDA premarket approval application for a drug-eluting stent is reviewed by:

Most frequent cause of IDE disapproval is insufficient non-clinical testing?

Which of the following is required for non-clinical testing of drug-eluting stents?

Indication changes for an approved drug-eluting stent usually requires which of the following trial designs?

Device iteration of stents is usually approved without new clinical data

Which of the following trial designs would you recommend to obtain regulatory approval for a novel drug-eluting stent?

All device iterations for an approved drug-eluting stent require clinical testing before they are implanted in patients?