US FDA urges national device evaluation system incorporating UDI

By Stewart Eisenhart, Emergo Group

Top US Food and Drug Administration officials are pushing for implementation of a national system for evaluating medical device pre- and post-market data including Unique Device Identification (UDI) to better address safety and effectiveness issues for patients and users.

Writing in the Journal of the American Medical Association, FDA Commissioner Robert Califf and Center for Devices and Radiological Health (CDRH) Director Jeffrey Shuren recently argued for establishing a system initially proposed in 2012. Such a system is necessary, according to Califf and Shuren, to allow regulators access to safety and effectiveness data across a device’s lifecycle.

Where current efforts fall short

Califf and Shuren note that US regulators currently monitor device safety and effectiveness primarily through post-market evaluation, an imperfect method. The authors identify several shortcomings of existing efforts:

• Premarket evaluations cannot fully demonstrate how a device will be used once fully commercialized
• Manufacturers are challenged to attract adequate patient populations for post-market studies, leading to delayed or diminished studies
• There are no penalties for manufacturers making good-faith efforts to conduct FDA-mandated post-market studies, even if such studies are delayed or diminished
• Adverse event reporting relies too heavily on clinicians identifying possible associations between events and devices, leading to underreporting
• “Spontaneous” adverse event reporting is not systematic enough
• Safety monitoring may be too reliant on manufacturers properly collecting and reporting data

Revisiting the NEST idea

In order to address these shortcomings, the FDA authors propose an approach already devised four years ago. In 2012, the agency first proposed establishing the National Evaluation System for Health Technology (NEST) for rapid identification of defective devices on the US market; the system would also provide data for use in premarket reviews of new devices.

NEST would utilize data from multiple sources, including device registries, electronic health records, UDI and clinical outcome claims data from the FDA’s Sentinel Initiative, and could be accessed by patients, physicians and healthcare systems to help inform treatment-related decisions.

Furthermore, according to Califf and Shuren, NEST implementation “could reduce the time and cost associated with developing evidence to support premarket approval, clearance, payer coverage and, reimbursement decisions” as well as reduce the number of device modifications and changes that require premarket review.

What’s next for NEST?

Given that the FDA has already laid some groundwork for NEST, what are the next steps for actual implementation? Challenges to developing a viable system are not insignificant; incorporating UDI information into medical claim forms, for example, would take considerable back-office workflow changes at the Centers for Medicare & Medicaid Services (CMS) as well as at healthcare providers’ and insurers’ billing systems.

Emergo’s US office will continue monitoring the situation and report on any progress on NEST implementation as it happens.

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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