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
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.