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Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health

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CDRH’s vision for medical device safety to protect patients and spur innovation of new products that are safer, more beneficial, and deal with unmet medical needs.

Graphic of Medical Device Safety Action Plan: Protecting Sufferers, Promoting Public Health cover. The cover includes the U. S. Food and Drug Administration logo and an image of a patient and doctor. The patient is a young White girl laying in a hospital bed talking with an older African-American physician in a healthcare establishing.

Medical Device Safety Action Plan

Providing patients with access to safe medical devices that meet their health care needs remains a top FDA priority. Typically the Medical Device Safety Action Plan: Protecting Patients, Promoting Public well-being outlines how the organization will encourage innovation to improve safety, discover security risks earlier, and keep doctors and patients better informed.

In the Health care Device Safety Action Strategy: Protecting Patients, Promoting General public Health, the FDA describes key actions it will take in the subsequent areas:

  • Establish a strong medical device patient safety net in the Combined States
  • Explore regulatory options to streamline and modernize timely implementation of postmarket mitigations
  • Spur innovation towards safer medical devices
  • Enhance medical device cybersecurity
  • Integrate the Center for Products and Radiological Health's (CDRH's) premarket and postmarket office buildings and activities to progress the use of a Complete Product Life Cycle (TPLC) approach to device safety

The FDA is updating measures to increase the protection of medical devices while continuing to create more efficient pathways to bring lifesaving devices to patients.

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