FDA Recognizes 25 Networking & Cybersecurity Standards

FDA has recognized a total of 25 standards on medical device interoperability and cybersecurity. These standards can be categorized into 3 groups:

1. Risk management standards for a connected and networked environment (IEC 80001 series and ASTM F2761-09)
2. Interoperability standards that establish nomenclature, frameworks, and medical device specific communications, including system and software lifecycle processes (ISO/IEEE 11073 series and ISO/IEC 15026-4)
3. Cybersecurity standards from the industrial control area most relevant to medical devices (IEC 62443 series)

These include standards for communication for specific device types such as thermometers, glucose meters, pulse oximeters and others.

The full list is at the link provided: FDA Recognizes 25 Networking Standards.