FDA Recognizes AAMI Standard and TIR
Posted July 22, 2019
The Food and Drug Administration (FDA) has designated an AAMI standard and technical information report (TIR), both published earlier this year, as recognized consensus standards. FDA-recognized standards are listed in an online database following the publication of a September 2018 final guidance.
ANSI/AAMI/UL 2800-1:2019, Standard for Safety for Medical Device Interoperability specifies a baseline set of requirements for assuring safe and secure interoperability for interoperable medical systems. The standard also provides guidance on key clinical and engineering properties essential for ensuring effective interoperability.
The first of a planned series of standards, ANSI/AAMI/UL 2800-1 focuses on medical device interoperability and is part of a joint effort with UL to address the “stubborn challenge” that interoperability poses for manufacturers.
AAMI TIR38:2019, Medical device safety assurance case guidance, provides guidance on the development of safety cases for the design of a medical device. For reviewers often faced with “thousands of pages of design documentation” when evaluating a device, according to the TIR, a safety case can help connect the dots.
“The purpose of a medical device safety assurance case is to tell this story of safety to the original designers, regulators, maintainers, integrators, and potentially even customers,” the TIR reads. “The safety case accomplishes this storytelling by taking the information developed under risk management processes and explaining what decisions were made, why the decisions are reasonable in the context of the intended use of the device, and where the reviewer can look for additional information.”
By attaining FDA recognition, voluntary consensus standards can then be used in premarket submissions to demonstrate conformity with relevant FDA regulations and requirements.
“Achieving FDA recognition helps to validate the partnership between AAMI and UL all those years ago and celebrates all those involved of the years of its development. At the end of the day, foundational documents like AAMI/UL 2800 improve safety and efficacy of interoperable medical devices as well as improve the quality of premarket submissions,” said Wil Vargas, director of standards at AAMI.
ANSI/AAMI/UL 2800-1 and TIR38 are available for purchase in the AAMI Store, www.aami.org/store. For more information on AAMI standards activities and how you can get involved, visit www.aami.org/standards.