FDA CDRH issues 2016 regulatory science priorities

The FDA’s Center for Devices and Radiological Health this week released its regulatory science priorities for fiscal year 2016, picking out 10 areas of focus.

The priorities will serve to improve safety, effectiveness, performance and quality of medical devices and radiation-emitting products, according to the agency, as well as facilitating the introduction of new devices into the marketplace.

“We envision that our external stakeholders can use these priorities to better target their regulatory science resources as well complement these activities. In addition, we believe that collaboratively we can work to maximize the impact of regulatory science research investments,” the agency wrote in the report.

Using “big data” to aid in regulatory decision making was 1st on the group’s list, followed by leveraging clinical experiential evidence and employing “evidence synthesis” across domains to aid in their regulatory decision making process. Big data has become a growing part of medical development, with data from implants and wearables changing how devices are created and designed.

The federal watchdog said it set improving the reprocessing of reusable medical devices as a top priority. Infections and superbugs being spread by contaminated bronchoscopes and other scope imaging devices were major issues over the last year, and the FDA said it was “critical to develop a comprehensive approach to address the effectiveness of reprocessing techniques.”

Developing computational modeling technology and enhancing the performance of health information technology and medical device cybersecurity will be a priority for the group. The move is a logical step, given the FDA’s warning about security flaws in medical devices it published this year.

The agency said it would work on incorporating “human factors engineering principles” into device design, saying that recalls and and adverse event reports indicated that it was important to be better able to assess device design and usability.

Developing new alternative approaches to standard batteries of biocompatibility tests was referenced by the FDA. Advancing methods to predict device clinical performance and materials, advancing the use of patient reported outcomes and collecting and using patient experience and preference choices in decision making were also on the FDA’s list of priorities.

The agency said the priorities will be “reassessed and updated periodically to reflect current regulatory science needs.”

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