US medical device regulators roll out data-driven science priorities for 2016

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration division responsible for oversight of the country’s medical device market has identified 10 science priorities it plans to pursue over the 2016 fiscal year.

The Center for Devices and Radiological Health’s (CDRH)goals and priorities for 2016 focus on utilizing data from digital, clinical and patient reporting sources to improve regulatory decisions regarding device clearances and approvals, as well as for developing new and updated rules and guidances for industry.

Based on these priorities, manufacturers currently cleared or approved to sell their devices in the US as well as firms planning on registering their devices with the FDA should have a better idea of which regulatory issues the CDRH will focus on in 2016, and how these priorities will affect compliance.

Below are some of the CDRH’s stated priorities.

Better use of available data

Several of the CDRH’s 2016 priorities involve more effective use of clinical and scientific data currently available. One such goal, leveraging “big data” for regulatory decision making, would entail more efforts to collect, analyze and distribute data from sources such as the human genome sequence and clinical trials databases in order to make more informed regulatory decisions, speed up scientific reviews and more quickly recognizing potential post-market issues for some devices.

A related 2016 priority, “leverage evidence from clinical experience and employ evidence synthesis across multiple domains in regulatory decision making,” essentially proposes that CDRH reviewers rely more on observational data collected on an after-market basis rather than primarily on data provided by manufacturers.

The CDRH has also made more effective use of data from patient reported outcome measures, or PROMS, one of its key data-related priorities for 2016. Too much variance in terms of quality and validity among the current crop of PROMs hinders wider use of these data sources, according to the CDRH, which requires development of more accurate instruments to make this data more useful.

Predicting clinical performance

With an eye toward better prediction of long-term clinical outcomes for devices, the CDRH has also set a goal of improving nonclinical assessments of device materials and mechanics. Better ability to discern how a device’s materials and properties clinically impact its performance, quality and safety could lead to improved device design and predictability of long-term performance, the CDRH argues.

Beefing up medical device cybersecurity

The rapid growth of mobile medical applications and technologies has highlighted the importance of cybersecurity, which is also reflected in the CDRH scientific priorities for 2016. The division plans to undertake more research to boost performance, interoperability and security of devices vulnerable to cybersecurity breaches.

More focus on reusables

The CDRH has identified reprocessing of reusable medical devices as a key concern, and plans on developing a comprehensive approach to ensuring effective reprocessing of these products to reduce or eliminate risks of infection in patients.

Such an approach must include device design, human factors, reprocessing instructions and methodologies and validation methods.

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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