Are You Following the FDA Medical Device Cybersecurity Guidance?
By Deb Bartel,
This post was recently updated on September 23, 2024
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.
About the Author:
Deb Bartel is a long-time leader of software quality and information system initiatives. Her expertise is built on 25 years of work in pharmaceuticals, medical device, chemicals, and textile manufacturing industries. She is a Principal at Praxis Life Sciences, where she is responsible for the Computer System Validation (CSV) and Software Quality Assurance (SQA) practice.
Deb has trained hundreds of Life Sciences professionals in risk-based computer system validation.
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