In January the FDA published draft cybersecurity recommendations for marketed medical devices to protect patient safety.
What’s new in this draft FDA guidance document:
Manufacturer’s Responsibilities
This guidance emphasizes that medical device manufacturers should monitor, identify and address cybersecurity vulnerabilities. This draft FDA document highlights that it is essential for device manufacturers to implement comprehensive cybersecurity risk management programs. These programs should focus on addressing the vulnerabilities which could permit the unauthorized access, modification, misuse, or denial of use of information that is stored, accessed, or transferred from a medical device, and could impact patient safety.
Download the FDA Guidance document here: Postmarket Management of Cybersecurity in Medical Devices
You may also be interested in the Pre-market guidance released in 2014
Not sure what to make of these new guidance documents? Talk to our CSV experts about how it may affect your medical device project.