NEST Solicits Public Comments of its Draft NEST Mark: RWD Source Quality Tool

The draft NEST Mark: Real‑World Data Source Tool is designed to assess the quality and general characteristics of RWD sources used in medical device regulatory applications. 

Originally developed and deployed by NEST as a pilot, the tool has since been refined by a multidisciplinary Working Group. The updated Version of the form incorporates best practices, FDA RWE Guidance, insights from NEST Test and Implementation Cases, the NEST Data Quality Framework, and the Working Group’s collective expertise to support the use of high‑quality data in RWE studies for medical devices. 

NEST is now seeking feedback from the wider medical device ecosystem on the updated version of the tool through a formal public comment period, which opens on May 4, 2026, and closes on July 3, 2026. All comments received will be blinded then reviewed by the Working Group for potential integration into the tool prior to the release of updated version later in the year.