Where are you getting these timetables? Could you provide any links to where you are finding this information?
I could certainly be misinformed I am no expert in the FDA approval process. However, my understanding is that the FDA is under no time-sensitive guidelines to approve or deny any application of any kind. Much less approval of a Class III medical device - Being that the Class III classification is for riskiest devices and the hardest process to get approval by.
Anyone else have any insights or opinions on this issue?
"In 2009, Shuren noted, it took an average of 427 days to for a decision on PMA. By 2015, that average was 276 days, a decrease of 35 percent in six years.
In contrast, in 2015, it took an average of 133 days for the agency to reach a decision on 510(k) applications."
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