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.
Other newly recognized standards in the area of software and informatics include an ANSI/AAMI standard on applying quality management system concepts to medical device data systems and an Institute of Electrical and Electronics Engineers standard on point-of-care communication.
AAMI’s TIR38 serves as a reference to guide the development of assurance cases, which aid in assuring and documenting the safety of medical device designs. The new document provides a high-level framework for creating safety assurance cases based on the experience and insights that were put into the designs of a medical device, including drug delivery combination products.
Reviewers are “often faced with thousands of pages of design documentation, with no overall summary as to why the designers believe the product is safe,” AAMI says. A safety case can help by telling the story behind the information generated in risk management processes. The examples are based on the premarket requirements that FDA set on infusion pumps in 2014.
With the agency’s recognition, both the standard on interoperability and the TIR on safety assurance cases can be used by industry to demonstrate conformity with FDA regulations and requirements. Most of the newly added standards fall under the medical device materials area.