Fewer 510(k) Submissions from US Medical Device Firms in 2015
Submitted by kBLASTER Team on
by Stewart Eisenhart at Emergo
In 2015, fewer US-based medical device companies submitted 510(k) applications to the Food and Drug Administration than at any point in the last five years.
Also last year, more 510(k) premarket notifications were submitted by foreign companies than at any point since at least 2011.
Overall 510(k) application numbers down
According to a new Emergo analysis of FDA 510(k) data, the number of 510(k) applications cleared by the FDA via...