News Feature | July 14, 2016

FDA Officials Call For National Medical Device Evaluation System

By Jof Enriquez,
Follow me on Twitter @jofenriq


Top officials at the U.S. Food and Drug Administration (FDA) have reiterated the need for a National Evaluation System for Health Technology (NEST) program that integrates data from clinical registries, electronic health records, and medical billing claims to gather more comprehensive evidence of medical device safety and effectiveness.

NEST evolved out of a series of FDA white papers issued in 2012 and 2013, and fleshed out in greater detail through subsequent policy papers and reports. FDA originally planned to create a dedicated postmarket surveillance system, but a task force later recommended changing this approach to a more comprehensive system, better suited to address optimal pre-market and post-market balance.

This national evaluation system for medical devices is envisioned to "generate evidence across the total product lifecycle of medical devices by strategically and systematically leveraging real-world evidence, and applying advanced analytics to data tailored to the unique data needs and innovation cycles of medical devices."

In a viewpoint column in The Journal of the American Medical Association (JAMA), FDA Commissioner Dr. Robert Califf and Dr. Jeffrey Shuren, director of FDA’s Center for Devices & Radiological Health (CDRH), explained the rationale for a unified system to better meet the FDA standard for marketing a medical device: RASE — reasonable assurance of safety and effectiveness.

Their article comes amid some criticism of FDA's perceived allowance of certain devices linked to adverse events to remain in the U.S. market, noted the Regulatory Affairs Professional Society (RAPS). Related, the Government Accountability Office reportedly said that up to 90 percent of FDA-mandated postmarket device surveillance studies over the past seven years were inactive.

The FDA officials acknowledged in their column that "many FDA-mandated postmarket studies for devices have been delayed, scaled back, or never finished," and that companies generally incur no penalties if they make a "good faith effort" in performing postmarket studies. They also accept that, since adverse events and device malfunctions largely depend on clinicians reporting a possible association, "underreporting is likely common."

However, Califf and Shuren wrote that NEST, as a "strategic approach to linking and using clinically based data sources, such as registries, electronic health records (EHRs), and claims data, could potentially reduce the burdens of obtaining appropriate evidence across the life cycle of a device. By leveraging clinical data and applying advanced analytics and flexible regulatory approaches tailored to the unique data needs and innovation cycles of specific device types, a more comprehensive and accurate framework could be created for assessing the risks and benefits of devices."

"In addition, the FDA’s Sentinel Initiative collects detailed claims data on the clinical outcomes of more than 100 million individuals in the US system. If the Sentinel Initiative would incorporate UDIs, it could provide a strong component of NEST," they wrote. They also called for speeding the proposed incorporation of UDIs (unique device identifiers) into EHRs to better track device issues when they arise.

Califf and Shuren also restated the planned formation of an independent coordinating center to lead NEST. The center will have multi-stakeholder representation from patients, health care professionals, health care organizations, payers, the medical device and digital health industries, and the government.

The two officials identified benefits to device manufacturers resultant of establishing a national device evaluation system: reduced cost and time for developing evidence to support premarket approval, clearance, payer coverage, and reimbursement decisions; reduced or eliminated need for postmarket studies and adverse event reporting; and reduced need for FDA premarket review of some device modifications (because more timely and informative evaluations could occur during routine data collection).

With NEST, device manufacturers could provide high-quality data to support informed decisions about when devices should be used in particular patients and how to mitigate risk across the life cycle of the device. NEST also could highlight opportunities for adding value through device enhancements and suggest development pathways for innovative technologies, the two officials wrote.

Shuren wrote last month in the FDA blog that NEST "could transform the historical tension between device innovation, patient access and patient safety into an alignment of interests to drive the development and more timely access to life-saving, life-enhancing, and life-advancing devices" for the American public.