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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 059 Date of Entry 12/19/2022 
FR Recognition Number 13-125
AAMI ANSI UL 2800-1-1:2022
Standard for Risk Concerns for Interoperable Medical Products
2.1 This Standard is applicable to interoperable medical products, including assembled systems of interoperable medical products that comprise or are intended to be incorporated into interoperable medical systems within an interoperable environment.
2.2 This standard specifies a baseline set of risk concerns for assuring safe and secure interoperability for interoperable medical systems.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of ANSI, AAMI, UL 2800-1:2019 [Rec# 13-109] will be superseded by recognition of ANSI, AAMI, UL 2800-1:2022 [Rec# 13-121], 2800-1-1:2022 [Rec# 13-125], 2800-1-2:2022 [Rec# 13-126], and 2800-1-3:2022 [Rec# 13-127]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 13-109] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 13-109] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
1. Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff. Issued September 2017

2. ANSI/AAMI/UL 2800-1:2022 - Standard for Medical Device Interoperability

3. ANSI/AAMI/UL 2800-1-2:2022 - Standard for Interoperable Item Development Life Cycle

4. ANSI/AAMI/UL 2800-1-3:2022 - Standard for Interoperable Item Integration Life Cycle

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Sandy Weininger
Standards Development Organizations
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
ANSI American National Standards Institute https://www.ansi.org/
UL Underwriters Laboratories, Inc. http://www.ul.com/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.