CDRH Talks Up Timeliness of NEST

Regulatory NewsRegulatory News | 19 March 2019 |  By 

Members of the committee governing the National Evaluation System for health Technology Coordinating Center (NESTcc), including US Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren, touted the timeliness of NEST in a commentary in Clinical Pharmacology & Therapeutics on Tuesday.

Shuren and NESTcc executive director Rachel Fleurence explain how the time for NEST has now come as certain “characteristics of medical devices have made the implementation of randomized controlled trials challenging.” These characteristics include “iterative and rapid changes to device design and the need to account for the role of operator expertise in clinical outcomes,” among several others. Other timely factors driving the need for NEST relate to active surveillance and health systems’ datasets.

NEST aims to address barriers to trials through greater use of real-world data (RWD) and real-world evidence (RWE) to support regulatory decision-making. The RWE innovation safety net has yet to become operational, despite the millions in funding it has received from both FDA and industry since 2016, but CDRH’s use of RWE for pre- and postmarket decisions grew by 193% from 2016 to 2017 compared to fiscal year 2015.

Shuren and Fleurence described how the first round of NEST test cases, which were selected last November, will result in new clinical study protocols and inform the second round.

“Studies are planning to report within 12−18 months of launch and if the exploratory stages of the test cases are successful, a full clinical study protocol will be developed with an appropriate analysis plan,” they wrote. “NEST's activities in 2019 will have an additional focus on the use of RWD and RWE for active surveillance.”

The shift from the current passive medical device surveillance system to one that allows for active surveillance by using safety signals in the ecosystem is one of the cornerstones of NEST.

“The timely and accurate detection of safety signals for medical devices is a high priority for the FDA,” Shuren and Fleurence added. “It is generally agreed that the combination of under‐reporting, incomplete reporting, and lack of denominator is not conducive to the robust and timely detection of safety signals.”

In addition to the commentary, last week, FDA Commissioner Scott Gottlieb and Shuren discussed how NEST will leverage RWE for the agency to act on its concerns around the evolving landscape of medical device materials.

Yet establishing NEST at its full capacity continues to hinge on additional funding.

“Despite all of the progress FDA has made and the promise of this system, NEST will require considerably more funding to fully meet its tremendous potential,” FDA said in its FY 2020 budget justification report. “Funding is the principal barrier to establishing this system.” This has remained true since at least the November 2018 updates to FDA’s medical device safety action plan. An additional $46 million was requested under the presidential budget for FY 2020 for NEST.

“Work remains to be done to set the data quality framework and ensure the use of appropriate methodological approaches that will meet FDA evidentiary standards,” Shuren and Fleurence concluded.



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