FDA ISSUES GUIDANCE ON CYBER SECURITY FOR MEDICAL DEVICES

On October 2, 2014, the FDA issued Guidance identifying cyber security issues that manufacturers of medical devices should consider in the design and development of their medical devices, as well as in preparing pre-market submissions for the devices. The goal is to reduce the risk to patients by decreasing the likelihood that device functionality is compromised by inadequate security.

The Guidance recommends that the manufacturers consider the cyber security core functions of identify, protect, detect, respond and recover. The Guidance then sets out a list of recommendations and considerations under each core function so as to maintain the security of the device. A pre-market submission should justify the security measures chosen for each medical device.

Contact me for a full copy of the Guidance, or you may go to the following website:

http://www.fda.gov/medicaldevices/deviceregulationandguidance/guidancedocuments/default.htm

By: Richard Sheinis, Esq.