Background

In light of the growing concern over cybersecurity and the increasing complexity of medical device supply chains, the Medical Device Coordination Group has released updated guidance on cybersecurity for medical devices (the Guidance). The Guidance is intended to supplement the essential requirements listed in Annex I of the Medical Devices Regulations (Regulations 745/2017 and

The Food and Drug Administration (FDA) published a draft update to its premarket cybersecurity guidance for device makers on October 18, 2018. The expanded draft guidance includes recommendations on tiered classification of cybersecurity risk, trustworthiness, cybersecurity bill materials, and device cybersecurity labeling that are specific enough to be helpful to manufacturers while at the same

The FDA represents the latest federal agency to show a focus on cybersecurity issues with the release December 28 of new guidance. While the prospect of network-enabled medical devices increasingly offers the promise of improved care and patient treatment, evolving technology and new-found connectivity present emerging security considerations as well.

The Food and Drug

Medical device companies and manufactures of other connected devices need to be attentive to the ever-increasing risk of a cybersecurity breach affecting their own devices and the hospitals and other health care organizations where their devices are connected. Taking these challenges into consideration, the FDA has issued several guidance documents concerning cybersecurity for medical devices.