Incomplete submissions will not be fully refunded, says FDA
This article was originally published in Clinica
The latest guidance from the FDA on medical device user fees and refunds notes that companies face steep financial penalties for submitting premarket approval applications (PMA) that are not sufficiently complete. If the application is so incomplete that the FDA refuses to file it, the agency said it will refund only 75% of the fee paid. And the money cannot be recouped. When the PMA is submitted again, the full fee will be levied, the FDA said.