FDA tweaks premarket rules
This article was originally published in Clinica
The FDA has updated its guidance on expedited review of premarket submissions in part to reflect the changes in last year's MDUFMA user fee bill. Applications granted expedited review are placed at the beginning of the appropriate review queue and receive additional review resources, as needed. If multiple applications for the same type of device are granted expedited review, they are reviewed based on a "first in, first reviewed" basis.