US user fees: 510(k)s spared major hike as PMAs (Pre-market Approvals) rise 16%
This article was originally published in Clinica
The US FDA is raising device user fees by 15.7% in all categories except 510(k)s in fiscal year 2005, the agency disclosed in a closed door meeting with industry last week. The increase for 510(k)s will be a mere 0.6%, bringing the fee to $3,502 for large companies and $2,802 for small companies.
You may also be interested in...
Resolution Medical teamed up with Carbon to introduce more than one million 3D-printed nasal swabs a week to address the shortage for COVID-19 testing.
Early results from the Low-Risk Bicuspid study of the Evolut transcatheter aortic valve replacement system showed low rates of all-cause mortality or stroke.
The reality is that many trials requiring hospital based tests and interventions cannot be replaced, but crisis will spur take up where practical.