$10,000 for a 510(k) application even if it is denied. What? Four years ago a 510(k) application was $5000.
And on Oct 1st, a De Novo 510(k) will cost $93,000. It has always been FREE. These new fees are basically taxes and the Executive Branch picks the rates. The FDA supposedly gives small companies a break, but I know a small orthopedic company that applied twice and was turned down twice. Just one more barrier to innovation.
Did Congress just kill medical device innovation? (Medical Device & Outsourcing)
The Medical Device User Fee Amendments bill that Congress passed this year is more than an FDA fees hike for device companies; it could inhibit innovation, says Michael Drues, a regulatory consultant based outside Boston.
That’s because MDUFA 2017 includes new user fees – about $23,000 for small companies and $93,000 for large companies – for requests for de novo device classifications. Drues, who has worked with both device companies and FDA, has clients speeding up de novo applications to get them turned in before the fees take effect on Oct. 1.
“I can think of no better way to stifle or kill innovation than by imposing those kinds of fees, specifically on the de novo,” Drues said. (See Drues moderate a regulatory panel at DeviceTalks Boston on Oct. 2.)
A better solution might be modest fees – perhaps $1,000 – $2,500 – for the hundreds of pre-submission meetings taking place at FDA each year, according to Drues.