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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 19-48
American National Standard for Evaluation of Wireless Coexistence
This standard specifies methods for assessing the radio-frequency (RF) wireless coexistence of equipment that incorporates RF communications. This standard specifies key performance indicators (KPIs) that can be used to assess the ability of the equipment under test (EUT) to coexist with other equipment in its intended operational environment.
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FDA recognition of IEEE, ANSI C63.27-2017 [Rec# 19-29] will be superseded by recognition of IEEE, ANSI USEMCSC C63.27-2021 [Rec# 19-48]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 19-29] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 19-29] will not be accepted.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and Food and Drug Administration Staff: Radio Frequency Wireless Technology in Medical Devices, Issued August 2013.

Guidance for Industry and Food and Drug Administration Staff: Electromagnetic Compatibility (EMC) of Medical Devices, Issued June 2022.

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 Contacts
 Jeff Silberberg
 Mohamad Omar Al Kalaa
 Seth Seidman
Standards Development Organizations
ANSI American National Standards Institute https://www.ansi.org/
IEEE Institute of Electrical and Electronic Engineers https://www.ieee.org/
FDA Specialty Task Group (STG)
General II (ES/EMC)
*These are provided as examples and others may be applicable.