FDA Policy/General

Securing Technology, Equipment Report

FDA has published a report, Securing Technology and Equipment (Operational Technology) Used for Medical Product Manufacturing, describing the agency’s efforts to address cybersecurity issues affecting medical product manufacturers through the development of a demonstration manufacturing line. “If the cybersecurity of manufacturers or other supply chain participants is compromised, it could drastically affect the health of thousands or millions of patients and consumers,” the report says.

Produced by the Office of Regulatory and Emerging Science in the Office of the Chief Scientist, the report says that each FDA Center “takes a concerted look at the technologies that affect the products and collaboratively approaches topics like cybersecurity which affect all of FDA’s product areas.”

The Office of Regulatory and Emerging Science says it is collaborating with the Office of Digital Transformation to apply the agency’s expertise to create a demonstration manufacturing line including software for manufacturing execution, operations, and lifecycle management, and digital hardware. FDA is not using this system to manufacture any products, the report says, but to identify and research cybersecurity and advanced manufacturing topics.

“Implementing such a system has allowed FDA to create a case study for a digitally integrated manufacturing line within a secure network,” the report says. “The program has compiled a basic list of standards and guidelines for good operational technology security practices and presents a case study of vulnerabilities and risk mitigation strategies.”

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