Harnessing Data at Heart of CDRH Regulatory Priorities

September 23, 2016

The Center for Devices and Radiological Health released its top-10 list of regulatory priorities for fiscal year 2017.

The list adds some new topic areas, including clinical trial design and precision medicine, and it fleshes out existing areas, such as patient-reported outcome measures and reprocessing of devices.

The top 10 list is as follows:

  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 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.

The center said priorities will be reassessed and updated as needed and will serve as a guide for making “strategic intramural research funding decisions.” Projects funded through intramural sources are evaluated using a defined set of metrics to make sure the projects are meeting their goals.

CDRH Director Jeffrey Shuren said during the Medical Device Innovation Consortium on Sept. 21 that harnessing data is at the heart of the center’s initiatives, so it’s no surprise that leveraging big data for regulatory decisionmaking is at the top of his list.

To that end, Shuren laid out his vision for harnessing big data and bringing patient preferences into the equation.

CDRH’s strategic priorities for 2014-15 focused on strengthening the clinical trial enterprise, and 2017 priorities build on these. Generating clinical trial data is the most expensive part of the regulatory requirements to get products to market, and there are serious limitations in conducting clinical trials with devices, Shuren said.

“You can’t conduct a trial that will answer all the questions on a medical device,” he said, because a clinical trial won’t give you a true risk-benefit profile. That true risk-benefit profile can only be answered “in the wild,” so the center is turning its focus on real-world use.

To get there requires the marriage of electronic health records and unique device identifiers to be able to track devices better. Terms will also need to be identified so that a national evaluation system for health technology (NEST) can solve those challenges in the postmarket setting.

The problem with clinical trials, he said, is that they are designed around the sponsor’s needs rather than the patient’s needs. Flexibility in the evidence-generating enterprise and digital health could enable the industry to “move away from the artificial constructs of premarket and postmarket cycles.”

“Every time we make a decision on a device, we face uncertainty,” Shuren said. “The question is how much do you accept?” The best way to answer that question is by using science to understand the uncertainty that patients are willing to accept under various circumstances, he suggested.

Value is increased by creating linkages between different data owners and pulling them together in an ecosystem to drive data standardization and create data use agreements.

A multi-stakeholder planning board for NEST is being run by the Duke Margolis Center for Health Policy, and a coordinating center run by the Medical Device Innovation Consortium will drive the activities of NEST, Shuren said (IDDM, April 11).

To expedite this, the FDA has committed $3 million to MDIC in fiscal year 2017 to get the enterprise off the ground. Under MDUFA IV the industry will give $6 million per year to the coordinating center that will translate into $33 million over the next six years for MDIC to bring this vision into a reality.

Read the CDRH report here: www.fdanews.com/09-22-16-FY17priorities.pdf; and read the NEST planning board report here: www.fdanews.com/09-22-16-NESTSeptreport.pdf. — Tamra Sami