HIMSS News

FDA Releases New Action Plan on Medical Device Safety

Medical device

Medical devices can offer benefits to patients and physicians alike, but also come with an inherent risk, which is why the Food and Drug Administration (FDA) on April 18 released its new Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health, which aims to improve patient safety, explore regulatory solutions and advance medical device cybersecurity nationwide. The new Action Plan outlines the FDA’s vision for how the FDA can continue to enhance its programs and processes to assure the safety of medical devices.

HIMSS plans to develop comments on the Plan to submit to FDA. Look for more information about how you can contribute to this effort in the near future.  

The FDA is looking to make sure new advances in technology that are enabling better capabilities and benefits are harnessed to bring added assurances of safety, so that more patients can benefit from new devices and address unmet needs. The plan focuses on five key areas:

  1. Establish a robust medical device patient safety net in the U.S.
  2. Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations
  3. Spur innovation towards safer medical devices
  4. Advance medical device cybersecurity
  5. 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 (TPLC) approach to device safety.

The agency will require medical devices to be capable of being updated and receive security patches and may force companies to publicly disclose cybersecurity issues that are detected, among other changes.

The FDA is also looking to explore how it can force labeling changes and other features more quickly, as opposed to relying on companies to voluntarily make changes once safety issues arise. This may mean the FDA may require additional training or education by providers.

In addition, FDA regulators are looking at ways to grant faster review of new devices that carry significant safety improvements but can't now be reviewed under FDA's breakthrough device program.