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.Apply for RFA FD 18 002
- 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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FAQs: FDA Cooperative Agreement for the NEST Coordinating Center (NEST CC)
What is this grant opportunity funding?
This FDA grant opportunity funds the creation and full implementation of the National Evaluation System for health Technology (NEST) Coordinating Center (NEST CC). The NEST CC is intended to serve as a national hub to organize and accelerate how real-world data (RWD) is used to evaluate medical device performance across the full product life cycle.
What public health problem is NEST designed to address?
The program is designed to address the fragmentation of medical device evidence. Data relevant to device safety and effectiveness is produced and held by many groups (health systems, clinicians, patients, payers, manufacturers, researchers, and government agencies), often in separate systems and collected for different purposes. This fragmentation makes it difficult to answer long-term safety and effectiveness questions, especially as devices are used in routine care, in diverse populations, and over extended periods of time.
Why is real-world data important for medical device oversight?
FDA has major responsibilities for premarket review and postmarket oversight, but many long-term questions increasingly depend on understanding performance in routine clinical practice. Growth in electronic health records, claims data, registries, mobile health tools, and other systems creates an opportunity to learn faster, but also creates challenges because the data can be inconsistent, fragmented, and not always suitable for regulatory-quality analysis.
What is NEST, and how is it structured?
NEST is envisioned as a public-private partnership network connecting multiple stakeholders so RWD can be transformed into real-world evidence (RWE) that is credible, timely, and useful for decisions affecting patients and the healthcare system. The NEST Coordinating Center is described as the operational centerpiece of this vision.
What is the role of the NEST Coordinating Center (NEST CC)?
The NEST CC is expected to be more than a research project. It is intended to manage partnerships, align incentives, set expectations, and build practical infrastructure that makes multi-site medical device evaluation feasible. It must coordinate relationships among partners and create an operating environment where RWE can be generated and used for regulatory decision-making as well as other stakeholder needs.
What kinds of decisions is NEST intended to support?
The NEST CC is expected to support regulatory decision-making and other stakeholder needs, including clinical practice improvement, payer coverage questions, and patient decision-making.
What are the key expected outcomes of the NEST CC under this opportunity?
Expected outcomes include improving the cost-efficiency of generating evidence, increasing access to and quality of device-related data, and improving data sharing while protecting privacy and proprietary concerns. The NEST CC 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 for long-term operation.
Does this opportunity build on prior FDA work?
Yes. The opportunity draws on prior FDA and expert recommendations for a stronger national postmarket surveillance system, including FDA's 2012 report on strengthening postmarket medical device surveillance and subsequent reports that culminated in the NEST concept. It also builds on an earlier FDA cooperative agreement that focused on initial steps to stand up the Coordinating Center, providing additional resources to fully implement NEST CC operations.
How is the scope of work organized?
The scope of work stays within the aims of the earlier program announcement (PAR-13-232) and is framed around four main goals: (1) implementing NEST through durable, multi-stakeholder partnerships; (2) developing new systems for data collection and/or analysis to support active, prospective identification of postmarket risks and evaluation of device performance; (3) developing and accessing high-quality data sources to support comprehensive device evaluation; and (4) supporting methodological approaches and systems that make RWE suitable for regulatory-grade decisions and useful across the device life cycle.
What does "durable, multi-stakeholder partnerships" mean in this context?
It means the awardee is expected to operate in a complex environment that includes public health interests, commercial interests, and patient/community expectations, and to convene and manage a multi-sector network consistent with NEST's public-private partnership model.
What does the opportunity mean by "active, prospective identification" of postmarket risks?
It emphasizes systems and approaches that can identify potential postmarket risks and evaluate device performance proactively, rather than relying only on passive reporting after problems arise.
What kinds of data sources are contemplated for NEST?
The opportunity references electronic health records, claims databases, registries, and mobile health tools, among other data systems. It anticipates using both established sources (registries, claims, EHRs) and potentially novel sources, including mobile health technologies, to supplement or enhance what is recorded in traditional systems.
How does the program address data quality and consistency issues?
The opportunity emphasizes developing and accessing high-quality data sources, suggesting focus areas such as common data elements, data quality controls, and governance that enables reuse across multiple stakeholders while maintaining appropriate protections.
What methodological work is expected as part of the NEST CC?
The NEST CC is expected to support and coordinate targeted research and demonstration projects that make the network workable and credible. This can include advancing statistical and epidemiological methods tailored to analyzing RWD, including approaches to handle confounding, missing data, device identification challenges, and changes in clinical practice over time.
What does "fit for purpose" mean for real-world data sources?
The opportunity highlights the need to validate whether particular RWD sources are appropriate for specific safety or effectiveness questions, recognizing that not every dataset can reliably answer every question.
How is patient-centered measurement addressed in this opportunity?
Patient-centered measurement is described as a priority, including developing and validating patient-reported outcomes and other outcome measures (including clinician-reported or caregiver-reported outcomes). These measures are expected to be integrated into linked datasets (such as coordinated registry networks) to ensure evaluation focuses on outcomes meaningful to patients.
Will the NEST CC work on linking data across systems?
Yes. 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.
What privacy or proprietary protections are expected?
The opportunity explicitly notes improving data sharing in ways that still protect privacy and proprietary concerns, and it emphasizes appropriate governance as part of enabling linkage and reuse of data.
Are pilot studies or demonstration projects part of the work?
Yes. The opportunity includes running pilot studies that demonstrate the real-world utility of RWE across different device categories, using established sources (registries, claims, EHRs) and potentially novel sources.
Does the scope include health economics analysis?
Yes. The opportunity highlights health economics work to quantify efficiencies and value, reflecting an expectation that NEST can improve evidence quality while also reducing time and cost compared with traditional approaches where appropriate.
How does the program incorporate patient engagement?
Patient engagement is treated as an explicit methodological area, including strategies to involve patients in shaping how data is collected, how it is interpreted, and how findings are communicated.
Is NEST limited to observational studies using real-world data?
No. The opportunity states that the NEST CC is expected to push beyond observational analyses when needed, including development and execution of prospective randomized clinical trials embedded within real-world data sources to generate evidence strong enough for regulatory decisions while leveraging routine-care infrastructure.
Does the grant address burden on clinicians and clinical settings?
Yes. The opportunity includes improving the efficiency of data capture in clinical settings, reflecting operational barriers clinicians face and the need to avoid evaluation systems that create excessive documentation burden.
What type of award mechanism is this?
This is an FDA cooperative agreement. That means substantial FDA involvement is expected during the period of performance, rather than a purely hands-off grant relationship.
Which agency is issuing the opportunity?
The opportunity is issued by the U.S. Department of Health and Human Services (HHS), Food and Drug Administration (FDA).
What is the Funding Opportunity Number and CFDA listing?
Funding Opportunity Number: RFA FD 18 002. CFDA: 93.103.
How many awards were anticipated?
The opportunity anticipated a single award.
What was the listed award ceiling?
The award ceiling is listed as $30,000 in the provided source text.
When was the opportunity posted, and what was the original closing date?
The original posting was created on June 14, 2017, with an original closing date of August 14, 2017.
Who is eligible to apply based on the information provided?
Eligible applicants are listed as "Others," with additional eligibility details referenced in the full announcement. The eligibility framing is 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.
What does success look like for the NEST CC under this grant?
Success is described as moving toward a coordinated national system where medical device safety and performance can be evaluated continuously using real-world evidence, supported by clear governance, validated methods, privacy protections, patient-centered outcomes, and a sustainable operating model, with the NEST CC serving as trusted infrastructure for faster learning and better regulatory and clinical decisions.
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