EMERGO SUMMARY OF KEY POINTS:

• US FDA has officially recognized a new consensus standard, ANSI UL 2900-2-1, for assessing network-connected medical device cybersecurity risk.
• US medical device market applicants may now utilize ANSI UL 2900-2-1 to demonstrate safety of their network-connected devices, accessories and software.
• FDA recognized a related standard, UL 2900-1 Ed. 2017, last year.

The US Food and Drug Administration has officially recognized a standard from the American National Standards Institute (ANSI) and UL targeting medical device cybersecurity.

FDA’s recognition of ANSI UL 2900-2-1—Standard for Safety, Software Cybersecurity for Network-Connectable Products, Part 2-1: Particular Requirements for Network Connectable Components of Healthcare and Wellness Systems as an official consensus standard now appears in the US Federal Register.

Using ANSI UL 2900-2-1 to address FDA cybersecurity requirements

As FDA 510(k) premarket notification and other medical device premarket submissions must now include data showing US market applicants’ efforts to mitigate cybersecurity risks and vulnerabilities, companies may utilize ANSI UL 2900-2-1 to demonstrate the safety of their network-connectable devices and accessories.

The ANSI UL 2900-2-1 consensus standard was developed to provide manufacturers as well as regulators with a consistent framework for cybersecurity risk assessment; the standard applies to all medical devices and accessories, as well as IVD devices, device data systems and health information technology products.

In summer 2017, FDA recognized a related standard, UL 2900-1 Ed. 2017—Standard for Software Security Network-Connectable Products, Part 1: General Requirements, which includes evaluations and assessments of network-connectable devices’ cybersecurity vulnerabilities.

Additional US FDA and medical device cybersecurity resources:

• US FDA 510(k) consulting for medical device and IVD manufacturers
• Cybersecurity testing for network-connected medical devices and software
• Regulatory consulting for digital health and mobile medical apps