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In a new draft guidance (for electrosurgical devices; but in our opinion representative of information needed for other devices) FDA stated that cybersecurity information including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.

Schedule Discussion with John F. Murray, Jr.

John is currently providing telephone and face-to-face meetings to discuss:  Cybersecurity, Part 11, 483 Response, design controls expectations for software documentation, and other topics.

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