Devices

CDRH Marks 10 Years of Cybersecurity Program

David McFarland

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As part of Cybersecurity Awareness Month, CDRH is marking the 10th anniversary of its cybersecurity program with an online post highlighting ways in which the program has contributed to patient safety in the last decade. CDRH Office of Strategic Partnerships and Technology Innovation director Suzanne Schwartz says the activities were:

  • 17 safety alerts issued;
  • 479 vulnerabilities identified;
  • 13 cybersecurity issues managed;
  • 31 cybersecurity resources produced;
  • 68 cybersecurity-related recalls issued; and
  • 6 cybersecurity team members added.

Schwartz also highlights a recent final guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, that has recommendations on cybersecurity considerations for devices, as well as recommendations for documentation in device premarket submissions. She says the agency is planning an 11/2 webinar on the guidance.

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