The link provided contains an November 4, 2009 memo from FDA on Cybersecurity. This memo reemphasizes some important points from FDA’s Cybersecurity guidance and urges Manufacturers and users to fulfill their mutual responsibilities. It states the following and then provides some addtional tips . The full text is avaiable at the link provided.
“FDA wants to emphasize the following:
Medical device manufacturers and user facilities should work together to ensure that cybersecurity threats are addressed in a timely manner.
The agency typically does not need to review or approve medical device software changes made for cybersecurity reasons.
All software changes that address cybersecurity threats should be validated before installation to ensure they do not affect the safety and effectiveness of the medical devices. “