RAC Devices Exam Prep Graded A+ -US High Risk

Number of Days for review of PMA - ANSWER-180 days How many routes to a PMA? - ANSWER-3 Routes: 1. 2 3 What makes a PMA unique (vs 510k)? - ANSWER--Must include section on clinical investigations on human subjects -Must include a seperate volume on QS for review by CDRH/OC (office of compliance) -Includes a premarket QMS inspection -Sponsor should update the PMA periodically during review (if a big update, might reset the clock) *SSED vs 510k summary *no substantial equivalence with predicate When in the process does a Quality System inspection happen for a PMA? - ANSWER-After filing review and before substantive review of submission What is the Day 100 meeting for a PMA? - ANSWER-DEFINE What does the SSED contain? - ANSWER-Device Description Preclinical Evidence Clinical Evidence FDA's decision regarding safety and effectiveness of device based on scientific evidence SSEDs are required for? Who creates the SSED? - ANSWER-Written by the FDA approval or denial of PMA approval of panel track PMA All ___ PMA's go before a panel review. - ANSWER-first of a kind For all other cases, panel review is done on an as-needed basis. Which part(s) of FDA performs a scientific review? - ANSWER-ODE or OIR Changes or revisions to the original PMA application are submitted to the FDA in the form of >> - ANSWER-Amendments (DURING REVIEW) Types of PMAs - ANSWER-Traditional Modular Product Development Process