The U.S. Food and Drug Administration (FDA) has incorporated ISA’s ISA/IEC 62443 series of industrial automation and control systems (IACS) security standards on the administration’s recognized consensus standards list.
The FDA recognizes industry standards developed by international and national organizations in satisfying portions of device pre-market review submissions and other requirements.
In addition, the FDA’s list of recognized consensus standards is designed to guide manufacturers who elect to declare conformity with industry benchmarks and to meet certain requirements for medical devices.
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The FDA cites the ISA/IEC 62443 series of standards in its publication entitled “Modifications to the List of Recognized Standards, Recognition List Number 032.”
Developed through the work of the ISA Committee on Security for Industrial Automation & Control Systems (ISA99), the ISA/IEC 62443 standards are designed to prevent and mitigate potentially devastating cyber damage to industrial plant systems and networks, which are commonly used in transportation grids, power plants, water treatment facilities, and other industrial settings.
“The FDA’s recognition of ISA/IEC 62443 serves as another major validation by a United States federal agency on the importance of these vital industrial cybersecurity standards,” says Terry Ives, Automation Federation chair and the 2013 ISA president. “Every member of the ISA99 Committee is to be commended for helping to develop these important industrial safeguards, which are being adopted throughout the world.”
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