FDA Announces 2019 Initiatives for Device Safety and Innovation

FDA Commissioner Scott Gottlieb and CDER director Jeff Shuren announced plans to promote device innovation and safety in 2019 using new premarket pathways as well as new safety and performance criteria.

They said the agency will move forward this year with plans to implement its National Evaluation System for Health Technology (NEST) to generate better evidence for use with device evaluations and regulations.

The agency also plans to put premarket pathways in place to encourage the development of innovations — such as patient safety enhancements — and create “a more robust patient safety net,” they said.