Emergo Analysis: Fewer 510(k) Submissions from US Medical Device Firms in 2015

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.

FDA 510(k) data for medical device premarket notifications in 2015Also 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 traditional, abbreviated and specialized routes fell in 2015, to their lowest level since 2011. In all, 3,025 510(k) submissions were cleared last year versus 3,203 in 2014 and 3,054 in 2013.

Foreign submissions rise

Less than 65% of 510(k) applications cleared by the agency in 2015 were filed by US companies, down significantly from 78% of applications in 2014. This decline may be explained at least partially in terms of currency exchange rates: A strong US dollar has made imported products including medical devices less expensive for US buyers, enabling foreign manufacturers to become more competitive. Fewer 510(k) applications from US companies may also reflect these firms’ awareness that they are challenged to compete with imported devices in terms of price.

Among foreign-based applicants, more than seven percent of 510(k) submissions came from Chinese companies—the single biggest foreign contingent of applicants over the past several years. Devices from China and other export-oriented Asian countries including Japan, South Korea and Taiwan made up nearly 15% of 510(k) submissions in 2015. Premarket notification submissions from German firms also increased, from just over two percent in 2014 to nearly four percent last year.

(Slightly) reduced review timeframes

Although (or perhaps because) the FDA cleared fewer 510(k) submissions in 2015 than in previous years, the agency did so at a slightly faster rate: 22% of premarket notification applications were cleared within three months of submission, and 61% of applications were cleared within six months. Within nine months of submission, 86% of applications received FDA clearance, while 95% of applications were cleared within 12 months.

These numbers indicate a slight improvement over the previous four years. Over the course of 2014, 21% of 510(k) applications were cleared within three months; 60% within six months; 82% within nine months; and 94% within 12 months.