USA – FDA Recognizes Standards for Medical Device Interoperability, Safety Assurance Cases

The latest batch of US Food and Drug Administration-(FDA) recognized consensus standards marked several firsts for the agency, including for interoperability and safety assurance cases.

FDA’s Center for Devices and Radiological Health (CDRH) updated its database of recognized consensus standards earlier this month with 90 new standards, bringing the total up to 1,385 from the last update in January. The database’s new batch includes the first standard for medical device interoperability and the first standard on medical device safety assurance cases.

The Association for the Advancement of Medical Instrumentation (AAMI) developed the standard on safety assurance cases as a technical information report (TIR), whereas the standard on safety for medical device interoperability was developed by AAMI in collaboration with the American National Standards Institute (ANSI) and Underwriters Laboratories, Inc. (UL).

ANSI/AAMI/ UL 2800-1: 2019—Standard for Safety for Medical Device Interoperability received FDA recognition last Monday as a “baseline set of requirements for assuring safe and secure interoperability for interoperable medical systems.” The standard is intended to support FDA’s 2017 final guidance on recommendations for premarket submissions of interoperable devices.
Similar consensus standards that recently received FDA recognition include a UL standard series that provided a two-pronged approach to the cybersecurity of connected medical devices.
AAMI said on Monday that the new safety standard on interoperability “is part of a joint effort with UL to address the ‘stubborn challenge’ that interoperability poses for manufacturers.” The joint effort speaks to an emerging trend among regulators to reinforce security requirements as part of premarket submissions, with new work to harmonize cybersecurity principles underway…