EMERGO SUMMARY OF KEY POINTS: The US FDA has now officially recognized the UL 2900 cybersecurity standard for medical devices. UL 2900-1 covers general cybersecurity requirements for network-connectable devices. FDA medical device applicants may now declare conformity to UL 2900-1 in order to address cybersecurity requirements as part of their US market registration.

EMERGO SUMMARY OF KEY POINTS: The US FDA will begin its Pre-Certification for Software (Pre-Cert) pilot program for digital health technologies considered medical devices in September 2017. Eligibility requirements for Pre-Cert participation as well as frequently asked questions have been published. As of now, US regulators have not set a deadline for applying to participate in the Pre-Cert program.

EMERGO SUMMARY OF KEY POINTS: A medical device and healthcare networking cybersecurity standard from UL is being recognized by the US Food and Drug Administration. The UL 2900 set of standards will enable US medical device market registrants to assemble evidence to demonstrate proper cybersecurity features for their products. Tools to demonstrate compliance with FDA cybersecurity requirements should help device manufacturers and medical software developers in both pre- and post-market environments.