CDRH Priorities Focus on Data, Quality
The FDA’s device center has tripled the number of staff with quality credentials to conduct on-site quality training and inspections.
The center had aimed to boost staff by 10 percent, but it ended up with a 300 percent increase, according to a report.
One of CDRH’s top priorities is the National Evaluation System for Medical Devices (NEST), which gathers real-world evidence to support regulatory decision making.
The agency acknowledged that some data may lack rigor compared to data collected in clinical trial settings, but said it may help support approval decisions. CDRH expects to release final guidance on this issue in 2017.