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Cybersecurity Awareness Month at the FDA

October is Cybersecurity Awareness Month

Cybersecurity Awareness Month raises awareness about the importance of cybersecurity and ensuring all Americans have access to resources to help be safer and more secure online.

Cybersecurity is also an important part of patient safety when it comes to medical devices. Maintaining strong cybersecurity is critical throughout the lifecycle of medical devices to keep patients safe and better protect the public health.

“CDRH continues to take steps to support a collaborative, multi-stakeholder environment that fosters communication about cybersecurity vulnerabilities that may affect the safety, effectiveness, and security of medical devices. The Best Practices for Communicating Cybersecurity Vulnerabilities to Patients is one of several actions we are taking during Cybersecurity Awareness Month to collaborate with the U.S. Department of Homeland Security (DHS) and other public and private partners to raise awareness about the importance of cybersecurity for the American public.” – Suzanne Schwartz, Director - Office of Strategic Partnerships & Technology Innovation, CDRH

At the FDA, the Center for Devices and Radiological Health (CDRH) is dedicated to ensuring medical devices are protected from cybersecurity threats by:

  • Providing guidance to help manufacturers design and maintain products that are cybersecure.
  • Informing the public and stakeholders about medical device safety concerns identified from new cybersecurity vulnerabilities.
  • Working across the healthcare sector to improve awareness of and address cybersecurity risks.
  • Participating in public and private partnerships to provide the healthcare sector with new tools and information to address medical device cybersecurity.

FDA’s Cybersecurity Awareness Activities in 2021

In 2021, the FDA continued to ensure medical device cybersecurity safety and awareness by:

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