AAMI/UL 2800 Standard for Medical Device Interoperability recognized by US FDA

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 manufactures.

AAMI TIR38:2019, Medical device safety assurance case guidance, provides guidance on the development of safety cases for 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 safe 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 Will 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.

Source: www.aami.org

Contact us at info@arqon.com.


Recent Posts

See All

North America - Nov/Dec 2019

USA: FDA medical device user fees for fiscal year 2020 increase by almost 6% USA: Comments sought on possible exemption of powered wheelchair stretchers from pre-market notification USA: Guidance docu

North America - Aug 2019

Canada: New fees and performance standards for medical devices effective 1 April 2020 Canada: New medical device incident reporting requirements for hospitals Canada: Post-market surveillance requirem

Drugs - Aug 2019

China : NMPA No. 2019/34 Issuance of Provision n Drug Quality Inspection and and Testing EU/US : EMA/FDA Analysis Shows High Degree of Alignment in Marketing Application Decisions Between EU and US. S

  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle
  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle



Call us:

   : +65 6909 0396

   : +65 9067 1432


Email us: info@arqon.com


© 2020 ARQon All Rights Reserved. 

  • LinkedIn - White Circle
  • YouTube - White Circle
  • Twitter - White Circle