News Feature | October 21, 2015

FDA Releases Regulatory Science Priorities For 2016

By Jof Enriquez,
Follow me on Twitter @jofenriq

Healthcare FDA Battle

The United States Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH) unveiled recently its ten major priorities for 2016. These goals are intended to foster regulatory science development, standards, and methodologies involved in the study the safety, effectiveness, performance, and quality of devices  – the overarching goal of the CDRH.

According to the CDRH report, the agency will focus on these ten priority areas in 2016:

  1. Leverage “Big Data” for regulatory decision making
  2. Leverage evidence from clinical experience and employ evidence synthesis across multiple domains in regulatory decision-making
  3. Improve the quality and effectiveness of reprocessing reusable medical devices
  4. Develop computational modeling technologies to support regulatory decision-making
  5. Enhance performance of digital health and medical device cybersecurity
  6. Incorporate human factors engineering principles into device design
  7. Modernize biocompatibility / biological risk evaluation of device materials
  8. Advance methods to predict clinical performance of medical devices and their materials
  9. Advance the use of patient-reported outcome measures (PROMs) in regulatory decision-making
  10. Collect and use patient experience/preference in regulatory decision-making

In the report, CDRH says the agency is looking to utilize "Big Data" warehouses to facilitate regulatory decision-making and to promote safety and quality of medical devices. Similarly, healthcare databases containing real-world, post-market clinical evidence of device performance would be tapped to aid reviews. This would include collecting patient experience data "to spur patient-centric medical product development."

In light of recent threats to public health, CDRH is making safety a priority, vowing to "develop a comprehensive approach" on device reprocessing techniques, taking into account factors such as device design and disinfection methodologies. On growing cybersecurity concerns, the agency says "research is needed to enhance performance and security of medical devices and interoperability, and to understand the impact of software modifications on device performance."

According to the report, the agency would develop human factors research tools and apply engineering principles into device design and usability, which are areas associated with many device recalls and adverse events.

In addition, the agency is looking to lessen dependence on animal testing by using alternative tools — such as chemical characterization, computational, or in silico modeling — to test the biological risk/biocompatibility of device materials. Likewise, alternative tools would be developed to discover how "new materials and technologies such as surface coatings, materials corrosion and additive manufacturing" could impact device quality, performance, and safety.

The Regulatory Science Subcommittee (RSS) of the CDRH Center Science Council, which was created in 2013, developed the priorities and needs assessments based on collections made by the RSS across all CDRH offices, according to a report from RAPS. The process of crafting the list of priorities is meant to be participatory from all stakeholders, in support of a better regulatory science environment.

"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," CDRH states in its report.