It’s the year of Big Data, and FDA has slated several priorities for fiscal year 2016 to improve regulatory science and introduce revised data quality standards.
From leveraging Big Data for regulatory decision making, to enhancing diverse population data for clinical trials and studies, the agency’s 2016 goals are guided by the medical device industry’s call for increased participation, transparency, and overall quality. What do these changes mean for medical devices?

First off, FDA and CDRH have set several regulatory science priorities for 2016, including:

  • Leveraging Evidence from Clinical Experience
  • Improving the quality and effectiveness of reprocessing reusable medical devices
  • Developing computational modeling technologies to support regulatory decision making
  • Enhancing the performance of Digital Health and medical device cyber security
  • Incorporating human factors engineering principles into device design
  • Modernizing biocompatibility / biological risk evaluation of device materials
  • Advancing methods to predict clinical performance of medical devices and their materials
  • Advancing the use of patient reported outcome measures (PROMs) in regulatory decision making
  • Collecting and using patient experience/preference in regulatory decision making

These priorities are undoubtedly affected by population data quality, participation, and transparency, another huge priority for the agency in 2016:

Data Quality, Participation and Transparency for Diverse Populations:

Within the above regulatory science priorities are concerns for data quality, participation and transparency for diverse populations.
The FDA insists they have made considerable progress on their data quality improvement initiatives. By way of staff training and outreach to stakeholders, FDA has updated or finalized guidance on demographic subgroup data. FDA’s Integrated Summary of Effectiveness (ISE) - Guidance for Industry, published in October 2015, is a 20-page document that describes FDA’s thinking regarding information the industry should include in an ISE, so as to provide an analysis with insights beyond those that are observable in individual trials.

Furthermore, Guidance on the Evaluation of Sex-Specific Data in Medical Device Clinical Studies, originally issued in August 2014, was updated and made available in conjunction with a training webinar for industry and FDA.

In addition, the Office of Minority Health (OMH) developed a plan to support research projects that lead to a better understanding of clinical outcomes in racial and ethnic subgroups. The Center for Devices and Radiological Health (CDRH), the Center for Drug Evaluation and Research, (CDER), and the Center for Biologics Evaluation and Research (CBER) have all modified their clinical review templates as well.



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