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# Shuren Outlines Real World Evidence Priority
- URL: https://www.fdaweb.com/shuren-outlines-real-world-evidence-priority/
- Published: 2018-03-09T12:00:00.000Z
- Updated: 2026-09-14T23:28:48.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140952

CDRH director **Jeffrey Shuren** says the Center’s real world evidence (RWE)initiative is a top priority and will help to obtain better and more efficient clinical evidence. For medical technology, RWE can fill gaps in the data used for premarket evaluation of devices and continued monitoring of post market safety, Shuren recently told the Alliance for a Stronger FDA. Shuren also discussed the establishment of the National Evaluation System for Health Technology ([NEST](https://strengthenfda.us11.list-manage.com/track/click?u=564aaf3ba56647cf536ecb9b0&id=30eebb2626&e=122703d8fb&ref=fdaweb.com)), which collects data across different platforms, including clinical registries, and electronic health records. “NEST, which has both public and private funding, needs additional investment, including an infrastructure buildout to develop data and analytical tools for more efficient recognition of safety concerns,” the Alliance said after Shuren’s presentation. 

An Alliance summary of Shuren’s talks noted he also addressed device quality and advanced manufacturing. He said the current Quality System Regulation (QSR) is constrained and does not allow manufacturing processes to be modified easily, “ultimately disincentivizing innovation in manufacturing,” according to the group. “CDRH is developing a new paradigm, whereby manufacturers would receive a certification to allow for a more flexible manufacturing environment,” it said. “Per Dr. Shuren, the new paradigm would be a voluntary program that is a surrogate to the QSR. CDRH is currently working with stakeholders through the Medical Device Innovation Consortium to develop the parameters of the program.”