To more efficiently generate better evidence for medical device evaluation and regulatory decision-making, the FDA is collaborating with medical device stakeholders to build the National Evaluation System for health Technology (NEST). In August 2016, the FDA awarded a cooperative agreement to the Medical Device Innovation Consortium (MDIC) to establish a Coordinating Center for NEST (NESTcc). The NESTcc provides governance for the NEST ecosystem, oversees infrastructure building, promotes standards, and monitors progress. The FDA is an active participant in NESTcc, building on work the FDA started in 2012.
NEST will generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices. The collaborative national evaluation system for health technology will link and synthesize data from different sources across the medical device landscape, including clinical registries, electronic health records and medical billing claims. A national evaluation system for health technology will help improve the quality of real-world evidence that health care providers and patients can use to make better informed treatment decisions and strike the right balance between assuring safety and fostering device innovation and patient access.
The FDA's Role in Establishing NEST
Establishing NEST was one of CDRH's 2016-2017 strategic priorities. The FDA is committed to actively supporting the creation and use of real-world evidence on device performance by undertaking a number of activities, including:
- Promoting implementation of UDI (Unique Device Identifiers) into health care systems that can be used in device evaluation;
- Funding a portfolio of activities through grants (PAR-13-202 and PAR-13-232) to support NEST development and implementation;
- Issuing final guidance to clarify how real-world evidence may be used to support pre- and postmarket regulatory decisions;
- Increasing access to and use of real-world evidence to support regulatory decisions;
- Working with the medical device ecosystem (federal partners, health care system, manufacturers, payers and patients) to build NEST.
Real-World Evidence Guidance Document
- Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices - Guidance for Industry and Food and Drug Administration Staff