Foundations for Developing NEST Mark
The FDA and medical device stakeholders are collaborating to build the National Evaluation System for health Technology (NEST) to efficiently generate better evidence for medical device evaluation and regulatory decision-making. In 2016, the FDA awarded the Medical Device Innovation Consortium (MDIC) a cooperative agreement to establish a Coordinating Center for NEST (NESTcc).
Under the Medical Device User Fees Amendments of 2017 (MDUFA IV), NESTcc was tasked with foundational commitments to develop and implement a framework that supports using real-world evidence (RWE) for medical devices. This involved establishing a governance structure, building the necessary infrastructure, and conducting Pilot (Test-Case) projects to evaluate RWE’s potential in regulatory contexts. An independent third-party assessment further reinforced this initiative, identifying the strengths and limitations of RWE in informing pre-market decisions for various device types. These foundational efforts set the stage for the transition to NEST Mark, a structured approach that advances using RWE in regulatory submissions.
Starting with MDUFA V in 2022, NEST shifted toward developing and implementing programs that support regulatory applications for medical devices with real-world evidence (RWE). These programs draw from feasibility work completed during MDUFA IV and reflect input from NEST stakeholders.
How NEST Mark Advances RWD-Informed Regulatory Submissions
Building on insights from its feasibility work, NEST launched NEST Mark—a process that structures the assessment and use of real-world data (RWD) for pre-market regulatory submissions for medical devices. This collaborative effort, involving the Center for Devices and Radiological Health (CDRH) and industry partners, applies clear, consistent methodologies and ensures that RWD studies meet high standards of data quality and study design, aligned with FDA Guidance Documents and NEST Frameworks.
The NEST Mark strengthens confidence in RWD’s relevance and reliability for meeting scientific and regulatory goals for medical devices, playing a key role in accelerating patient access to safe and effective health technologies.
Call for Implementation Cases to Leverage NEST Mark
Launching implementation cases is crucial to developing NEST Mark. Following the NEST Mark process, these cases aim to create efficient regulatory applications that use RWE through data and research partners in the NEST Marketplace or NEST Research Network. Learnings from these cases will shape NEST Mark’s final version.
Contact us or review our Open Calls to learn more about NEST Implementation Cases and how to engage with this pioneering pathway for RWE regulatory submissions.
