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Compliance In Focus
Posted by John Lehmann on Thu, Jun 9, 2016

FDA's Device Evaluation Program is Underway

FDAs_Device_Evaluation_Program_is_Underway.jpgThe Food and Drug Administration (FDA) has been working closely with Industry negotiators and other stakeholders for years to establish a National Evaluation System for medical devices. The goal of establishing such an infrastructure is to generate real world evidence to efficiently monitor the long-term safety and effectiveness of medical devices. In the FDA’s Center for Devices and Radiological Health (CDRH) strategic priorities report for 2016-2017, establishing a National Evaluation System for medical devices is a priority, however according to the CDHR Director, Dr. Jeffrey Shuren the system may not be ready until fiscal year 2023, if the agency cannot secure funding.

According to an article in The Gray Sheet, it mentioned that Dr. Shuren received assurance from the FDA’s Commissioner, Dr. Robert Califf that the agency will provide the initial funding for a coordinating center that would help build the system. However, the money will only be provided if additional funding is forthcoming from Congress or increased user fees, which are being negotiated in the Medical Device User Fee Act (MDUFA IV).

The FDA argues that the system, also known as “NEST,” could help create a new regulatory paradigm for the agency. NEST could help devices be approved with less premarket data and more supporting data in the postmarket setting. FDA also hopes the data generated will help researchers and physicians when determining which treatments are more effective in the long-term, which can help personalize treatments for patients.

So how does FDA secure funding for NEST? The funding is tied to recommendations from the planning board tasked with developing the postmarket medical device surveillance system framework. According to Dr. Shuren, the planning board recommended raising $50 million annually, with $25 million from appropriated dollars and $25 million from user fees.

The FDA stated to Industry stakeholders during a MDUFA IV negotiation that NEST is a priority for the agency in order to develop real world evidence. However, Industry negotiators are not entirely sure of the promised benefits of real world evidence that the agency is claiming.

With the funding for the NEST program still pending, what are your thoughts on the proposed benefits of the NEST program and do you believe Congress and Industry negotiators will agree to the necessary funding to make the program a success?

The History of Clinical Research

photo credit: via photopin (license)

Topics: CDRH, NEST, National Evaluation System


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