Medical device safety, cybersecurity focus of FDA action plan

Medical device safety, cybersecurity focus of FDA action plan

Market news |
The U.S. Food & Drug Administration (Silver Spring, MD) has released an action plan outlining how it plans to enhance its programs and processes to assure the safety of medical devices.
By Rich Pell


The plan – Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health – describes how the agency will encourage innovation to improve safety, detect safety risks earlier, and keep doctors and patients better informed.

“Advances in material science, digital technology and advanced manufacturing are contributing to an unparalleled period of invention in medical devices,” says FDA Commissioner Scott Gottlieb, M.D., in an accompanying statement. “New devices offer more opportunities to improve health than at any time. Last year, the FDA approved a record number of novel devices. This reflects an advancing pace of innovation that’s resulting in many more potentially lifesaving new medical products.”

“Although medical devices provide great benefits to patients, they also present risks,” says Gottlieb. “And we are focusing equal attention on advancing new frameworks for identifying risks and protecting consumers.”

Specifically, the action plan focuses on five key areas:

  • Establish a robust medical device patient safety net in the U.S.
  • Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations
  • Spur innovation towards safer medical devices
  • Advance medical device cybersecurity, and
  • Integrate the Center for Devices and Radiological Health’s (CDRH) premarket and postmarket offices and activities to advance the use of a Total Product Life Cycle approach to device safety.

In terms of cybersecurity, the plan focuses on software transparency, mandatory patching, and the creation of an investigative body to deliver a “universal view of device oversight” and improve medical device cybersecurity. The FDA also says it intends to seek the authority and funding to develop a CyberMed Safety (Expert) Analysis Board, a public-private partnership that would complement existing device vulnerability coordination and response mechanisms and serve as a resource for device makers and the agency.

“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,” says Gottlieb. “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.”


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