The FDA has just increased user fees.
$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 Amen...
