NESTcc Selects 8 RWE Test Cases for Medical Devices

Regulatory NewsRegulatory News | 05 November 2018 |  By 

The National Evaluation System for health Technology Coordinating Center (NESTcc), which is mutually funded by the US Food and Drug Administration (FDA) and industry, announced Monday it has selected a total of eight real-world evidence (RWE) test cases to evaluate medical device performance in clinical settings.
NESTcc based its selections on applications medical device manufacturers submitted in January under a public call for concepts initiated last year and subsequently updated to extend the deadline until the end of the month.
The selected RWE test cases “will answer questions of importance to the medical device ecosystem through collaborations between NESTcc network collaborators and participating industry partners,” according to NESTcc. The current 12 NESTcc network collaborators include several prominent health care providers, such as the Duke University Health System and Mayo Clinic, as well as data partners MDEpiNet and Anthem’s HealthCore, among others.

Some of the newly selected projects also encompasses the European medical device regulation. This coincides with the vision that NESTcc chair Michell-McMurry Heath, who also serves as Johnson & Johnson’s worldwide VP of regulatory and clinical affairs and global head of evidence generation, recently discussed in an interview with Focus for NESTcc's operations to be applied on a global scale and serve a role in regulatory harmonization.  
The projects to be tackled during the first round of test cases will be executed through collaborations with Abbott, Adhesys Medical, Johnson & Johnson, and W.L. Gore & Associates, Inc. as industry partners, the coordinating center noted.
Objectives are centered on exploring the feasibility for industry to use the real-world data sources from NESTcc’s initial set of partners and areas in which it could help reduce costs associated with transactions, such as with contracting and Institutional Review Boards.
“The first round of test cases includes projects along the 510(k) and premarket approval regulatory pathways, across five disease areas, and throughout the medical device total product lifecycle,” NESTcc noted. The second round will seek to build on the objectives of the first.
NESTcc is run by the public-private partnership known as the Medical Device Innovation Consortium, which received $3 million in seed funding from FDA in 2016 to begin the work around the envisioned RWE-based innovation safety net dubbed NEST for firms, researchers and regulators alike.


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