FDA UPDATE: Cybersecurity Concerns Infiltrate the Medical Device Community

Cybersecurity Concerns Infiltrate the Medical Device Community – Risks Related to Medtronic Insulin Pumps Can Cause Serious Injuries or Even Death

The FDA has been concerned about this type of attack and has required Cybersecurity in their 510(k) submissions. Here is an incident that has major implications for the device industry and resulted in a Class I recall.

Medtronic expanded its 2018 recall of remote controllers used with either the MiniMed 508 insulin pump or the MiniMed Paradigm family of insulin pumps due to potential cybersecurity risks. Medtronic updated recommendations for people who may still be using the remote controllers, including instructions to stop using and return the remote controller.

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.

Questions?

If you have questions on the FDA requirements of cybersecurity or need assistance with FDA 510(k)s and the cybersecurity requirements, mdi can be of assistance.

mdi will continue to monitor this issue. For more information please contact mdi at: info@mdiconsultants.com and ref: Cybersecurity