A discussion paper has been published by the US FDA Medical Device Regulations focussing on vulnerability and cybersecurity issues where companies from the industry can comment until August 17, 2021. The main aim of this report is to strengthen and improve the cybersecurity processes related to the servicing of Medical Devices. The four main areas mentioned are 

  • Privileged access
  • Identification of cybersecurity vulnerabilities and incidents
  • Prevention and mitigation of cybersecurity vulnerabilities
  • Product lifecycle challenges and opportunities.

The FDA is hoping to get an input on the above mentioned areas and also the following questions 

  • Cybersecurity Challenges and Opportunities in servicing Medical Devices
  • Are the areas of focus mentioned correct
  • How can the entities servicing Medical Devices contribute to strengthening the cybersecurity of medical devices?

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