> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# U.S. Companies Submitting Fewer 510(k)s: Consultants
- URL: https://www.fdaweb.com/u-s-companies-submitting-fewer-510-k-s-consultants/
- Published: 2017-04-06T12:00:00.000Z
- Updated: 2026-09-14T22:16:28.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138392

The latest annual Emergo study of 510(k) submissions to FDA looked at some 15,000 applications cleared by the agency between 2012 and 2016 and determined that U.S. manufacturers are submitting applications less frequently than in previous years, while submissions from foreign countries have increased. The firm’s [report](https://www.emergogroup.com/blog/2017/03/emergo-study-fda-510k-submissions-us-companies-decline?ref=fdaweb.com) says that overall, numbers of 510(k) submissions have fallen over the past three years, while review times have increased.

The total number of 510(k) submissions cleared by FDA hit a four-year low in 2016, Emergo says. Some explanations for the trends advanced by the consultants include a strong U.S. dollar, more stringent FDA review practices, and more export-oriented commercialization efforts by Chinese and German manufacturers.

“One of the most striking findings in our study shows that FDA premarket notification submissions from firms in the U.S. constituted more than 80% of all such submissions in 2012,” the report says. “In 2016, that percentage had fallen to just under 60%.” Over the same four-year period, it says, submissions from Asian and European firms, particularly those in China, Germany, and South Korea, roughly doubled, although they all remain in single-digit percentages.

“It’s hard to pinpoint why fewer U.S. companies are submitting 510(k) applications,” says Emergo vice president of global marketing **Chris Schorre**. “FDA has certainly raised the bar with regard to requirements for testing and clinical data over the last few years, and the associated cost of getting 510(k) clearance in the U.S. has risen.”