FDA to prioritize role of med device big data, cybersecurity in 2017

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In its regulatory priorities for 2017, the U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) lays out 10 areas of focus to ensure safety, effectiveness and quality of medical devices and products that use radiation.

“CDRH regulatory science also aims to advance our nation’s public health by helping to facilitate device innovations and ensuring that devices using state-of-the-art technologies are available to improve and maintain Americans’ health,” the center’s report (.pdf) notes.

The 2017 priorities differ from the previous year in that there are new topic areas, such as clinical trial design and precision medicine, and greater detail given to topics already identified.

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Here’s a breakdown of some of those priorities:

  • Big data: The CDRH looks to leverage big data for better decision-making. It wants to see creation of infrastructure, analytical tools and information retrieval to support collection and use of large amounts of data relevant to medical devices. Information from data warehouses, the report’s authors add, can detect possible post-market issues as well as lead to improved regulatory decision-making.
  • Device performance: There must be a better understanding of impacts on devices, according to CDRH, regarding materials, surface coatings and advanced manufacturing techniques--which can affect the quality and safety of the tools. CDRH wants more advanced and validated testing methods, as well as use of smart implants to monitor and report on device performance.
  • Cybersecurity: The center notes that cybersecurity is a big threat to medical devices. Because of that, there must be further research to enhance security of devices and software, which can be achieved through studies that find “which categories of software modifications could have significant negative effects on device safety or effectiveness.” In addition, research is needed for a method to rate IT vulnerabilities in the healthcare environment.

“CDRH envisions a positive feedback model of regulatory science prioritization and implementation to best serve the center’s mission, vision and to promote efficient use of center resources,” the authors write.

The FDA last month released recommendations and guidance for devicemakers on when they must report modifications made to products on the market.

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