US FDA Cybersecurity Requirements for Medical Devices

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Are you marketing a wireless, networked, or interconnected medical device in the United States? If so, you can expect intense regulatory scrutiny from the US Food and Drug Administration (FDA).

The FDA pays special attention to cybersecurity vulnerabililties in medical devices, and has established cybersecurity control requirements for network, wireless, and similar technologies. Manufacturers must take extra measures to ensure the cybersecurity of their device throughout its lifecycle. In this white paper, we address your biggest questions about US regulatory requirements for wireless medical devices, including:

  • What is required in a FDA 510(k)?
  • What is required in a FDA Premarket Approval (PMA)?
  • What post-market risk management measures does the agency recommend?
  • What are the components of a compliant cybersecurity framework?

We answer all of these questions and more in this 4-page white paper.