The National Evaluation System for Health Technology Coordinating Center (NESTcc) announced this past Monday that they have selected eight real world evidence (RWE) test cases to properly assess medical device performance in clinical settings.

These selections are derived from applications previously submitted in January after NESTcc requested proposals so they can build a better case for using RWE for both regulatory and coverage decisions for medical devices.

According to NESTcc, the chosen RWE test cases “will answer questions of importance to the medical device ecosystem through collaborations between NESTcc network collaborators and participating industry partners,”

NESTcc chair Michell-McMurry Heath recently explained in an interview with Focus that he wants operations of the center to be applied on a global scale and play a role in regulatory harmonization.  This may soon come to fruition as some of the selected cases also contain European medical device regulation.

Goals such as reducing costs with transactions including contracting and Institutional Review Boards are going to be a prime focus as the industry uses real world data sources from NESTcc’s initial set of collaborators.

NESTcc commented that “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.”  These projects include collaboration with companies such as Abbott, Adhesys Medical, Johnson and Johnson and W.L. Gore and Associates. The second round of test cases aims to build on the goals of the first.


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