A shakeup is on the horizon for how pre- and post-market experts at US FDA's device center interact under a new "Total Product Life Cycle" initiative. The scheme aims to provide the agency with better visibility of products, device-makers and various device classes from cradle-to-grave to help guide its pre- and post-approval decision-making.
"One of the things we’re doing inside the agency, inside CDRH specifically, is looking at how we work together. Not only are we trying to figure out how we can...
With pre- and post-market teams working together, the agency can respond more quickly to critical safety issues because it will have immediate access to expanded array of data streams.
