FDA device center officials hope they can balance the substantial resources that they would need to invest into products accepted into CDRH’s newly proposed “Expedited Access PMA” pathway with a more straightforward, less- intensive review process, but the jury is still out, Center Director Jeffrey Shuren says.
“It may turn out that we spend more resources upfront with an innovator, but actually save some resources later on because we have been able to work out a regulatory...