1. Medtech Insight

FDA’s Cyber Device Regulations Demand Focus on Security, Webinar Says

 
• By Elizabeth Orr

A recent webinar highlighted the need for manufacturers to monitor, manage, and address software vulnerabilities under FDA cybersecurity policy. Important elements include a thorough software bill of materials, coordinated vulnerability disclosure, and maintaining system security.

Cybersecurity
• Source: Shutterstock

Developers of devices that include software need to be aware of the US Food and Drug Administration’s “cyber device” expectations, two former FDA reviewers said during a late February webinar.

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