FDA issued a reminder to the medical device industry on November 4 that cyber security is a shared responsibility. The agency stressed the following points in its reminder:
-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.
The agency also recommended simple steps that manufacturers could take to improve cybersecurity. You can learn more here.
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November 5th, 2009
