Can I read 510(k) FDA Review Cycle Trends on EtoBox?

510(k) FDA Review Cycle Trends by Anonymous u3HABDD is a document available to read on EtoBox.

What is 510(k) FDA Review Cycle Trends about?

This document contains several charts and graphs summarizing statistics related to 510(k) medical device submissions to the FDA from 2000 to 2015. Some key findings presented are: - The percentage of 510(k) submissions requiring additional information from the FDA on the first review cycle has fluctuated between 37-77% from 2000-2015. - The percentage requiring additional information on the second review cycle has decreased from 35% in 2002 to 8% in 2014. - Average total time to decision for 510(k) submiss

Author

Anonymous u3HABDD

Language

EN