FDA-Premarket Submission Cybersecurity Info Draft

In a new draft guidance (for electrosurgical devices; but in our opinion representative of information needed for other devices) FDA stated that cybersecurity information including but not limited to the following should be provided:

  • Confidentiality assures that no unauthorized users have access to the information.
  • Integrity is the assurance that the information is correct – that is, it has not been improperly modified.
  • Availability suggests that the information will be available when needed.
  • Accountability is the application of identification and authentication to assure that the prescribed access process is being done by an authorized user.

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Learn FDA expectations for software validation for computer systems, quality system software, manufacturing and production process software, and engineering tools. Email training@softwarecpr.com for more info.

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