RAC Device Exam Questions and answers Graded A+

RAC Device Exam Questions and answers Graded A+ What did the safe medical device act do? - ANSExtended AE reporting to user facilities, required 510ks with SE, recall authority General controls - ANSEstablishment reg and device listing, GMP, labels, clearance before marketing What controls are required by the 3 US classes? - ANSClass 1 - general controls. Class 2- General and special controls (which include special labeling, PMS, and performance data) Class 3- general, special, and PMA What are special controls? - ANSSpecial labeling, PMS, performance data Which devices classes generally have a 510K or PMA? - ANSClass 2 = 510K, Class 3= PMA What is substantial equivalence? - ANSSame intended use, technology, no new questions of safety/effectiveness, as safe as the marketed device All clinical studies of investigational devices need IDE approval when? - ANSBefore the start of the study FDA Admin meeting - ANSprivate or public meeting used for review of disputes, applications, approvals FDA Regulatory Communications - ANSrelease of regulations, guidance documents Citizen Petition - ANSFormal request to FDA to refrain from an admin action Types of Qsub meetings - ANSPresub, informational, study risk determination, early collab, submission issue request, PMA Day 100, Breakthrough designation request