510(k) Turnaround Better in States With Strong Industry Presence
States with large pockets of medical device manufacturers appear to have an advantage at the FDA level, a recent study of 510(k) clearances suggests.
The study data set included 12,406 510(k) clearances from 45 states or U.S. territories, according to research released by LifeScience Alley. Seven states had filed at least 500 510(k)s each, 18 had filed 100 to 500, and 22 had filed fewer than 100. Minnesota, California and Massachusetts alone made up 36 percent of the cleared 510(k)s.
Devicemakers in Minnesota and Massachusetts fall under the national average in terms of the time it took to get 510(k) clearance, while California, Florida and Pennsylvania fall above the national average. The average 510(k) filed by a Minnesota-based company from 2010 to 2014 took 110 days to clear, while Massachusetts manufacturers took 133 days, both below the 145-day national average. California, Florida and Pennsylvania took 149 days or longer.
A potential factor benefiting Minnesota’s device industry is that employees move fairly freely between large companies and smaller start-ups, taking expertise and training with them.
While California has a relatively high number of 510(k)s, the slow processing may be due to the larger geographic size of the state and the fact that the medtech industry isn’t concentrated in one area of the state like the software industry in Silicon Valley.
The slowest states for 510(k) clearance were Hawaii at 260 days, Idaho at 236, New Mexico at 224, Oklahoma at 193 and Kentucky at184.
Experienced devicemakers — those with more than 10 510(k) clearances — saw an even faster turnaround at 103 days in industry-heavy states, versus 130 days nationally. — Elizabeth Orr