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Big Data Tops FDA’s 2016 Priorities

Embracing data tools speaks to less than a handful of CDRH’s priorities. Device companies can expect CDRH to take a deeper look at materials and reusable devices.

The ten regulatory science priorities for 2016 include:

    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

      •  FDA has received a growing number of submissions that include simulation data, leading the agency to believe that computer modeling and simulation (M&S) has the potential to supplement traditional models used to evaluate devices. The development of M&S techniques in conjunction with validation methodologies may help companies get devices to market utilizing less-burdensome approaches.
    5. Enhance performance of digital health and medical device cybersecurity
    6. Incorporate human factors engineering principles into device design

      •  FDA isn’t the only regulatory body with an eye on human factors. Manufacturers can expect greater focus on the topic from the EU, China and Japan. Three human factors problem areas for device manufacturers are people requirements, design requirements and testing requirements. 
    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 in regulatory decision making
    10. Collect and use patient experience/performance in regulatory decision making

CDRH weights the priorities equally. The list, developed by the Regulatory Science Subcommittee, serves as a guide for the division’s strategic research and funding decisions and alerts device companies on how to target their regulatory resources to complement FDA’s activities.

Carolyn LaWell is ORTHOWORLD’s Content Manager. She can be reached by This email address is being protected from spambots. You need JavaScript enabled to view it..


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