New white paper highlights the need to secure operational technologies used in medical product production.


The US Food and Drug Administration (FDA) has released a new white paper emphasizing the importance of integrating cybersecurity into the connected technologies that support medical product manufacturing.

Modern manufacturing environments increasingly rely on operational technologies—such as programmable logic controllers and distributed control systems—that are often connected to networks but not originally designed with cybersecurity in mind. As a result, the FDA indicates that it can be difficult to determine what, when, and where network communications are occurring, potentially increasing the risk of cyber incidents.

In the white paper, Securing Technology and Equipment (Operational Technology) Used for Medical Product Manufacturing, the FDA notes that commercially available manufacturing equipment may not natively comply with national or international cybersecurity standards. To address this, the agency urges manufacturers to adopt state-of-the-art cybersecurity practices through careful system design and configuration.

The paper is intended to raise awareness and provide a summary of best practices to help reduce vulnerabilities across the US medical product manufacturing sector and its supply chain.

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