Medical devices get a new safety action plan

In an effort to protect patient safety and promote public health, the US Food and Drug Administration (FDA) released a new Medical Device Safety Action Plan. 

The FDA regulates over 190,000 different medical devices that are manufactured by more than 18,000 companies in more than 21,000 medical device facilities worldwide. Such medical devices provide a broad range of medical benefits, but also poses risks according to the FDA guidance

The Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health “outlines a vision for how FDA can continue to enhance our programs and processes to assure the safety of medical devices throughout the TPLC, to provide for the timely communication and resolution of new or increased known safety issues, and to advance innovative technologies that are safer, more effective and address unmet needs.”

The FDA action plan and guidance focuses on the following:

  1. Establish a robust medical device patient safety net in the United States.
  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’s) premarket and postmarket offices and activities to advance the use of a TPLC approach to device safety.

The FDA emphasizes the importance of a “Total Product Life Cycle” (TPLC) approach to medical devices throughout the lifecycle of medical devices (e.g., premarket review, manufacturing quality and postmarket surveillance).

The FDA will continue to maintain a robust program in evaluating the safety and security of medical devices throughout their lifecycles.

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