> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Keep Device Real-World Evidence Under NESTcc: MDMA
- URL: https://www.fdaweb.com/keep-device-real-world-evidence-under-nestcc-mdma/
- Published: 2023-03-20T12:00:00.000Z
- Updated: 2026-09-14T18:20:41.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5154019

Medical Device Manufacturers Association (MDMA) says it would be wasteful and duplicative to use medical device user fee funds to advance real-world data/evidence (RWD/RWE) activities with any new organizations. Responding to a request for comments, MDMA president **Mark Leahy** recommends that FDA and industry continue to develop the National Evaluation System for Health Technologies Coordinating Center (NESTcc).

“MDMA continues to support the concepts that NESTcc was established to advance,” Leahy says, which include a multi-stakeholder governance, focusing on creating and testing a robust research network, and developing consensus committees of subject matter experts to advance the generation of reliable RWE. Lessons learned from NESTcc should be “leveraged as FDA further develops its use of RWE and updates existing guidance,” he says. “Additionally, advancing new and innovative approaches requires diverse perspectives, expertise, and practical experiences. NESTcc’s governance structure includes all the relevant stakeholders and their leadership that is needed to guide the work forward. We recommend that FDA continue to leverage NESTcc as a collaborative community and broaden its focus on advancing RWE for regulatory activities.”

Leahy says there are also several steps that could be taken to strengthen NESTcc. “We recommend that NESTcc create more transparency in its decision-making and enhance the authority of the governing committee over NESTcc’s programs and activities,” he says. “These steps will ensure the organization moves forward to become a true public-private partnership with meaningful multi-stakeholder governance.”

Additionally, Leahy says user fee funds should be used for activities that support and inform FDA’s continued work to address the existing policy and programmatic challenges in developing new draft guidances “focused on promoting the shared development of least burdensome best practices in study conduct, analytical methods, and approaches for demonstrating the ‘fit-for-purpose’ of real-world data sources. Additionally, the MDUFA V funds should advance CDRH’s RWD/RWE training programs and best practices for review.”