Thursday, April 28, 2016

RAC US Exam Question No 33

Question No 33:

When FDA declares a device from a 510(k) application to be Not Substantially Equivalent (NSE) and requires a PMA. What is the most practicable first option for a company at this stage?

A. File a PMA immediately
B. Petition CDRH to down-classify the device (de novo process)
C. Resubmit a 510(k) with new data to demonstrate the device is at least as safe and effective as the predicate
D. Submit this product for approval in Europe

Answer: C

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