NEST update: Recommendations for early-phase projects of US medical device evaluation system

By Stewart Eisenhart, Emergo Group

EMERGO SUMMARY OF KEY POINTS:

• The FDA and other stakeholders are moving forward incrementally with their National Evaluation System for health Technology (NEST).
• NEST managing boardmembers recommend demonstration projects as early-stage activities of the NEST program.
• Recommended early-stage NEST projects focus on pre-and post-market evidence evaluations.

The planning board of a US Food and Drug Administration project to develop a nationwide evaluation and monitoring system for medical devices has issued new recommendations for implementing early-stage components of the program.

The latest report on the proposed National Evaluation System for health Technology (NEST) focuses on early-stage activities the program’s Coordinating Center should undertake in order to establish viable networks of data partners and sources, methodological expertise and best practices, and communication processes for both project participants and the public.

“The Planning Board recommends the Coordinating Center use demonstration projects as a way to develop these shared resources while also showing the value of a nationally coordinated approach to bridging efforts and closing the gaps in medical device evaluation,” the report states.

The report divides implementation of these demonstration projects into two phases. Phase one projects should include balancing pre- and postmarket device evidence development efforts, as well as improving safety surveillance of devices in order to eventually achieve an active national surveillance system.

Phase two project recommendations include boosting and improving data collection and integrating health technology systems for better Class II device regulatory evaluations; pushing more use of patient-mediated data sharing platforms; and devising ways to measure device value within the NEST infrastructure.

Manufactures whose devices are registered for sale in the US should keep track of NEST developments, as the eventual implementation of such a system will have significant effects on their FDA compliance requirements.

Stewart Eisenhart covers medical device regulatory affairs for Emergo Group.

The opinions expressed in this blog post are the author’s only and do not necessarily reflect those of MassDevice.com or its employees.

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