Creation and Implementation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC) | RFA FD 18 002

Opportunity Information: Apply for RFA FD 18 002

This FDA grant opportunity funds the creation and full implementation of the National Evaluation System for health Technology (NEST) Coordinating Center (NEST CC), a national hub meant to organize and accelerate how real-world data is used to understand medical device performance across the entire product life cycle. The core public health problem behind the program is that medical device evidence is produced and held by many different groups (health systems, clinicians, patients, payers, manufacturers, researchers, and government agencies), often in separate systems and for different purposes. FDA has a major role in premarket review and postmarket oversight, but long-term safety and effectiveness questions increasingly depend on understanding how devices perform in routine care, in diverse populations, and over time. At the same time, the growth of electronic health records, claims databases, registries, mobile health tools, and other data systems creates both an opportunity to learn faster and a challenge because the data are fragmented, inconsistent, and not always fit for regulatory-quality analysis.

NEST is envisioned as a public-private partnership network that connects these stakeholders so real-world data (RWD) can be transformed into real-world evidence (RWE) that is credible, timely, and useful for decisions that matter to patients and the healthcare system. The NEST CC is the operational centerpiece of that vision. Rather than being just a research project, the Coordinating Center is expected to manage partnerships, align incentives, set expectations, and build the practical infrastructure that makes multi-site device evaluation feasible. The opportunity draws heavily on prior FDA and expert recommendations that called for a stronger national postmarket surveillance system, including FDAs 2012 report on strengthening postmarket medical device surveillance and subsequent reports that culminated in the NEST concept. An earlier FDA cooperative agreement focused on the initial steps to stand up the Coordinating Center; this funding opportunity builds on that foundation by providing additional resources to fully implement NEST CC operations and begin executing NEST as a functioning national evaluation system, consistent with goals referenced in draft Medical Device User Fee Act (MDUFA) performance objectives for FY 2018-2022.

The NEST CCs responsibilities are broad and practical. It must coordinate relationships among partners and create a functioning environment where real-world evidence can be generated and used for both regulatory decision-making and other stakeholder needs (such as clinical practice improvement, payer coverage questions, and patient decision-making). Key expected outcomes include improving the cost-efficiency of generating evidence, increasing access to and quality of device-related data, and improving data sharing in ways that still protect privacy and proprietary concerns. The Coordinating Center is also expected to promote best practices for device evaluation, develop transparent and streamlined approaches for assessing and communicating device safety and effectiveness, and establish a sustainable business model so the system can endure beyond a single period of federal support.

The scope of work stays within the aims of the earlier program announcement (PAR-13-232) and is framed around four main goals. First, the program supports implementation of NEST through durable, multi-stakeholder partnerships, meaning the awardee must be capable of operating in a complex environment that includes public health interests, commercial interests, and patient/community expectations. Second, it supports development of new systems for data collection and/or analysis that enable active, prospective identification of postmarket risks and evaluation of device performance, not just passive reporting after problems arise. Third, it emphasizes development of and access to high-quality data sources that can support comprehensive device evaluation by multiple stakeholders, suggesting a focus on common data elements, data quality controls, and governance that enables reuse. Fourth, it supports methodological approaches and systems that make RWE suitable for regulatory-grade decisions and useful across the device life cycle, from early deployment through long-term monitoring, updates, and potential safety actions.

A major function of the NEST CC under this opportunity is to support and coordinate targeted research and demonstration projects that make the overall network workable and credible. The funded work may include advancing statistical and epidemiological methods tailored to RWD analysis (for example, approaches to handle confounding, missingness, device identification challenges, and changes in practice over time). It also includes methods to validate whether particular RWD sources are fit for purpose, since not every dataset can reliably answer every safety or effectiveness question. The opportunity calls out patient-centered measurement as a priority as well: developing and validating patient-reported outcomes and other outcome measures (including clinician-reported or caregiver-reported outcomes) that can be integrated into linked datasets such as coordinated registry networks, so evaluation focuses on results that are meaningful to patients rather than only what is easiest to capture.

The program also anticipates modern data capture approaches, including the use of mobile health technologies to supplement or enhance what is recorded in EHRs, claims, and registries. Because meaningful device evaluation often requires connecting records across systems, the NEST CC is expected to advance methods for data linkage while ensuring patient privacy and appropriate governance. Another major deliverable area is running pilot studies that demonstrate the real-world utility of RWE across different device categories, using both established sources (registries, claims, EHRs) and potentially novel sources. The opportunity further highlights health economics work to quantify efficiencies and value, reflecting an expectation that NEST will not only improve evidence quality but also reduce time and cost compared with traditional approaches where appropriate. Patient engagement is treated as an explicit methodological area too, including strategies to involve patients in shaping how data is collected, interpreted, and how findings are communicated.

Importantly, the NEST CC is expected to help push beyond observational analyses when needed. The scope includes development and execution of prospective randomized clinical trials embedded within real-world data sources, with the goal of generating evidence strong enough for regulatory decisions while leveraging routine-care infrastructure to improve feasibility and reduce burden. Finally, the opportunity includes improving the efficiency of data capture in clinical settings, which speaks to real operational barriers clinicians face and the need to avoid creating evaluation systems that add excessive documentation burden.

From an administrative standpoint, this is an FDA cooperative agreement (meaning substantial FDA involvement is expected during performance, not just a hands-off grant). The opportunity is issued by the Department of Health and Human Services, Food and Drug Administration, under Funding Opportunity Number RFA FD 18 002 (CFDA 93.103). It anticipated a single award with an award ceiling of $30,000 (as listed in the source text), with the original posting created June 14, 2017 and an original closing date of August 14, 2017. Eligible applicants are listed as "Others" with additional eligibility details referenced in the full announcement, consistent with the public-private partnership nature of the Coordinating Center and the expectation that the awardee can convene and manage a multi-sector network.

Overall, the grant is designed to move the United States toward a coordinated national system where medical device safety and performance can be evaluated continuously using real-world evidence, with clear governance, validated methods, privacy protections, patient-centered outcomes, and a sustainable operating model. The NEST CC is the entity responsible for turning that concept into a working, trusted infrastructure that can support faster learning, better regulatory and clinical decisions, and improved patient outcomes.

• The Department of Health and Human Services, Food and Drug Administration in the agriculture, consumer protection, food and nutrition sector is offering a public funding opportunity titled "Creation and Implementation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.103.
• This funding opportunity was created on Jun 14, 2017.
• Applicants must submit their applications by Aug 14, 2017. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Each selected applicant is eligible to receive up to $30,000.00 in funding.
• The number of recipients for this funding is limited to 1 candidate(s).
• Eligible applicants include: Others (see text field entitled Additional Information on Eligibility for clarification).

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