News Feature | September 26, 2016

Big Data, Cybersecurity, Precision Medicine Among Top Priorities For FDA in 2017

By Jof Enriquez,
Follow me on Twitter @jofenriq

FDA Food Code Improvement

The Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA) announced recently its top ten regulatory science priorities for 2017. As they were in 2016, "Big Data" and medical device cybersecurity remain as focus areas, with precision medicine and clinical trial design joining the list of priorities for next year.

New areas were gleaned from increased needs submissions from staff, and some existing priorities were expanded or consolidated for clarity, according to CDRH.

"As a result we were able to identify new topic areas (i.e. clinical trial design and precision medicine) as well as describe existing topic areas in greater detail. Although the area of human factors is not prominently identified as a priority, it is still an unmet need and is reflected in the descriptions of other FY 2017 top ten priorities (e.g., infection control and predicting medical device clinical performance). Patient reported outcome measures and patient preference were combined as patient input and the reprocessing priority was renamed to the more inclusive topic of infection control," states the CDRH report.

The CDRH’s top ten priorities for 2017 are:

  1. · Leverage “Big Data” for regulatory decision-making
  2. · Modernize biocompatibility and biological risk evaluation of device materials
  3. · Leverage real-world evidence and employ evidence synthesis across multiple domains in regulatory decision-making
  4. · Advance tests and methods for predicting and monitoring medical device clinical performance
  5. · Develop methods and tools to improve and streamline clinical trial design
  6. · Develop computational modeling technologies to support regulatory decision-making
  7. · Enhance the performance of Digital Health and strengthen medical device cybersecurity
  8. · Reduce healthcare-associated infections by better understanding the effectiveness of antimicrobials, sterilization, and reprocessing of medical devices
  9. · Collect and use patient input in regulatory decision-making
  10. · Leverage precision medicine and biomarkers for predicting medical device performance, disease diagnosis, and progression

CDRH is looking to utilize "Big Data" warehouses that host genomics, anatomical, biological, clinical trial, and device performance and safety data to help detect potential emerging post-market issues. Also, it said that data from "real-world experience, insurance, Medicare and Medicaid claims, clinical trials, imaging and next generation sequencing can help improve medical device designs, become training sets for artificial intelligence devices or be used to develop precision diagnostics."

The agency, starting early this year, issued guidance documents covering other areas included in the priority list for 2017, including two new draft guidances and one final guidance related to human factors in product design.

In January, FDA issued a cybersecurity guidance on postmarket devices, urging manufacturers to create a structured and systematic comprehensive cybersecurity risk management program amid growing threats against medical device and health IT systems. That document followed final guidance for premarket cybersecurity management during the design stage of device development. Last month, FDA released draft guidance clarifying when to submit a 510(k) for device and software modifications.

In July, it finalized guidance on adaptive clinical study designs applied throughout the clinical development program of a medical device.

FDA also has moved to include more patient perspectives on regulatory decision-making and device development. It formed last year a Patient Engagement Advisory Committee (PEAC) to act as a resource for FDA on device regulation affecting patients and their families.

CDRH also wants to develop nonclinical methods for assessing the long-term monitoring capabilities and predictive capacity of smart implants, and to look for better computational and statistical tools to speed device evaluation, according to Healthcare Dive.