At least one PMA and one 510(k) product type will need to be piloted on the nascent US National Evaluation System for health Technology (NEST) by fiscal year 2019 under a draft agreement between FDA and industry.
The NEST system is being developed by FDA and private- and public-sector partners to capture real-world evidence from a robust network of registries, databases and other sources and to leverage that data to support post-market surveillance and pre-market innovation. The effort got a boost in August when industry groups and the US agency agreed to include $30m in user-fee funding to pilot NEST as part of the MDUFA IV reauthorization that will roll out at the start of FY 2018