FDA Urges Medical Product Makers to Beef Up OT Security
bankinfosecurityAgency: Rising Threats Put Manufacturing Supply Chains, Patient Safety at Risk Marianne Kolbasuk McGee (HealthInfoSec) • June 25, 2025

After years of pushing medical device makers to address the cybersecurity of their products, the Food and Drug Administration is now urging all medical product makers to carefully consider the security of their connected operational technologies, including their advanced and "smart" devices used in their manufacturing and supply chains.
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Manufacturing infrastructures are vulnerable to ransomware and other cyberattacks as the industrial internet of things and smart technologies are becoming ubiquitous, the FDA said in a newly released white paper, "Securing Technology and Equipment - Operational Technology - Used for Medical Product Manufacturing."
But these connected operational technologies "have historically been designed to prioritize consistent functionality over cybersecurity," the FDA said.
"Consequently, it is sometimes difficult to tell what ...
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