FDA Action Plan Promotes Innovation to Make Medical Devices Safer

Posted April 20, 2018

The Food and Drug Administration (FDA) has published an action plan outlining how it will work to improve the safety of medical devices. The 17-page plan encourages medical device manufacturers to innovate in ways that improve patient safety by scaling back regulatory roadblocks, increasing the use of data, and streamlining FDA operations.

“The action plan recognizes that safety and innovation should go hand in hand,” said FDA Commissioner Scott Gottlieb in a statement. “The best technological advances should lead to more lives saved and fewer adverse events. We want to take new steps to encourage manufacturers to make even modest iterative changes to their devices, if these new advances and adaptations will lead to a reduction in risk to patients.”

The plan includes few immediate changes but lists several proposals intended to help identify and mitigate safety risks throughout a device’s life cycle, keep physicians and patients more informed, and spur greater innovation related to device safety. These ideas include:

  • Establishing a medical device patient safety net that leverages the National Evaluation System for health Technology (NEST) and unique device identifiers (UDIs). Such a system would “help improve the quality of real-world evidence that FDA can use to detect emerging safety signals quickly and take appropriate actions,” as well as help manufacturers address potential issues to improve their devices, according to the plan. To that end, the FDA will seek more funding for NEST to improve its active surveillance capabilities.
  • Looking for ways to more quickly implement postmarket mitigations, either by leveraging current statutory authorities or seeking to develop new ones.
  • Creating a competitive marketplace for device quality as well as incentivizing manufacturers to make devices safer. The FDA said it would encourage more staff interaction with manufacturers that are developing a device “intended to be safer than currently available technologies but that do not otherwise meet the Breakthrough Device criteria,” potentially as part of a new program. To “create a competitive marketplace for device quality,” the FDA would build upon its Case for Quality Initiative with a pilot program to “establish organizational performance metrics and device quality metrics that can be tracked in a ‘dashboard-like’ format to facilitate continuous monitoring and, accordingly, improved visibility to potential manufacturing, product quality, or patient safety issues.”
  • Keeping pace with emerging cyberthreats and vulnerabilities. That would include requiring manufacturers to design medical devices with the capability to receive software security updates, provide a “software bill of materials” as part of the FDA’s premarket submission process, and disclose cybersecurity vulnerabilities to customers. The FDA is also exploring the development of a public-private CyberMed Safety (Expert) Analysis Board, which could assess high-risk or high-impact vulnerabilities and “could be deployed in the field to investigate a suspected or confirmed device compromise at a manufacturer’s or FDA’s request.”
  • Integrating the Center for Devices and Radiological Health’s premarket and postmarket offices and activities to advance the use of a more holistic “total product life cycle” approach to regulating device safety through a previously announced reorganization.

“This new action plan outlines our vision for how the FDA can continue to enhance our programs and processes to assure the safety of medical devices,” Gottlieb said. “Our aim is to make sure that the new advances in technology that are enabling better capabilities and benefits are also harnessed to bring added assurances of safety, so that more patients can benefit from new devices and address unmet needs.”

The trade association AdvaMed responded positively to the FDA’s action plan, citing support for UDI development, bolstering cybersecurity defenses, and using real-world evidence to evaluate device performance.

“The current regulatory framework has served the American public well as it has continued to evolve to keep pace with innovation, but we believe every process can be improved and welcome discussion of any proposal that would positively impact patient safety and access, ” said AdvaMed President and CEO Scott Whitaker in a statement.

However, the consumer advocacy group National Center for Health Research (NCHR) criticized the FDA action plan, saying to the Associated Press that the plan contains few changes and “many sections that will please the device industry.”

"FDA's safety strategies for medical devices are still years away from effective implementation," said Diana Zuckerman, president of NCHR. "Overall, the report indicates that the FDA's approval standards for medical devices remain completely inadequate."

The FDA is soliciting public feedback on the plan, which can be submitted at www.regulations.gov.