Creation and Implementation of the National Evaluation System for Health Technology (NEST) Coordinating Center (CC)

Description

A comprehensive understanding of medical device performance is vital to public health for the United States and around the world. While FDA plays an important role in evaluating and reasonably ensuring the safety and effectiveness of medical devices, data that supports evaluation is generated and used by a large variety of other stakeholders within the medical ecosystem for many disparate purposes. FDA's mission to protect and promote public health continues after the approval of a new medical product into the postmarket space where it is of vital importance to understand real-world use and associated outcomes. Proliferation of medical data systems has presented additional challenges and opportunities for an enhanced understanding of medical devices throughout the total product life cycle. In recognizing the scope of the issues related to the understanding of medical devices, FDA has proposed formation of a multi-stakeholder public-private partnership National Evaluation System for health Technology (NEST). NEST is envisioned as a network of partners including patients, healthcare practitioners, healthcare facilities, payers, medical device manufacturers, researchers, and federal agencies all of whom generate, analyze, interpret and apply findings from data generated in the "real world" to critical issues related to the understanding of medical devices and their impact on patients. In September 2012, FDA released a report, "Strengthening Our National System for Medical Device Postmarket Surveillance." (http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/ucm301912.htm). This report, recognizing the shared responsibility of postmarket surveillance, highlighted the need for FDA to work collaboratively with a broad array of stakeholders to develop the necessary systems and scientific methodology to facilitate a comprehensive, in-depth understanding of medical device use and associated health outcomes. This report was followed by several additional reports, and their recommendations, which have culminated in the call for development and implementation of NEST. A critical component to the implementation of the expert recommendations is the establishment of a NEST coordinating center (NEST CC). The NEST CC will be responsible for managing relationships among the partners and facilitating use of real-world data for the understanding of medical devices in a way that is meaningful for the stakeholder communities. The CC should monitor, promote use, and facilitate infrastructure development for use of real-world evidence for medical device evaluation (both for regulatory decision making and the other needs of stakeholders). The NEST CC (as set out in the report: " Strengthening Patient Care: Building a National Postmarket Medical Device Surveillance System" available at https://www.fda.gov/downloads/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDRH/CDRHReports/UCM435112.pdf) should: optimize the cost of, access to, quality of, and sharing of data related to the evaluation of medical devices; promote the adoption of best practices for device evaluation; develop a transparent and streamlined process for evaluating and disseminating medical device safety and effectiveness information; develop a sustainable business model for a national medical device evaluation system. The existing award, "Public-private partnership coordinating center for National Evaluation System" FD005806, has a scope to identify and implement the steps necessary to establish the NEST CC and its operations. This RFA is to build upon the scope of the existing award by incorporating the stated purposes and goals listed in Section H.2 of the draft Medical Device User Fee Act Performance Goals and Procedures Fiscal Years 2018 Through 2022 as well as to provide additional resources to fully implement the NEST CC and begin operations of NEST to support the use of real-world evidence in the understanding and evaluation of medical device use and patient outcomes. The scope will remain within the aims of the original announcement, PAR-13-232, including: 1) To support the implementation of the NEST through sustainable multi-stakeholder partnerships. 2) To develop new systems of data collection and/or analysis to permit prospective active medical device postmarket risk identification and medical device performance evaluation that facilitates postmarket surveillance; 3) To support development of and access to high quality data sources that can be used in comprehensive evaluation of medical device performance and associated outcomes by multiple stakeholders; and 4) To develop methodological approaches and/or systems that facilitates the use of real-world evidence for regulatory decision making, and for uses by other stakeholders, throughout the entire device lifecycle. The NEST CC will support and coordinate research projects within the medical device ecosystem. Such projects include: 1. statistical and epidemiological methods to support RWD analysis efforts; 2. methods to validate RWD sources as "fit for purpose"; 3. development and validation of patient reported outcomes (and other objective outcome measures, e.g. clinician-reported outcomes, caretaker-reported outcomes, etc.) that can be used within linked data sets (coordinated registry networks) to better assess results that are most meaningful to patients; 4. use of mobile health technologies to capture and supplement data reported within EHR, administrative claims, registries, and other similar RWD sources; 5. methods for RWD linkage and to ensure patient privacy; 6. pilot studies that demonstrate the utility of RWE in a variety of medical device spaces, using established and/or novel RWD sources (e.g. registries, administrative claims, EHR, etc.); 7. health economics studies to develop methods and demonstrate the efficiencies of RWE for medical device evaluation; 8. ‎methods for the optimal engagement of patients in the development and use of RWD for medical device evaluation and subsequent dissemination and interpretation of results; 9. development and execution of prospective randomized clinical trials within RWD sources that generate a level of evidence sufficient for medical device regulatory decision making; and 10. techniques to improve efficiency of data capture in clinical settings.

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