The FDA has lengthened the average 510(k) clearance time, +37% in 4 years

Analysis of US FDA Data Shows 37% Increase in 510(k) Clearance Times Since 2006 (QMed)

Key findings from Emergo Group include:

• More than 53% of FDA 510(k) submissions are cleared by the agency in less than 3 months. More than 80% are cleared within 6 months.

• In 2006, 510(k) applications cleared by the FDA took an average of 96 days. For submissions made in 2010, the average time from submission to clearance is projected at 132 days, a 37% increase.