Is there a user fee for a Real-Time PMA Supplement?
Yes. As with all fee-paying submissions, the fee for a Real-Time PMA Supplement is due upon submission of the supplement. If FDA receives the supplement prior to payment, we will place the file on hold until we receive payment and notify you by facsimile.8 FDA begins its review when the Office of Financial Management notifies CDRH or CBER that payment has been received and we have received the PMA submission. See FDA’s MDUFMA page for information on remitting user fees.
