| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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059
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Date of Entry 12/19/2022
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FR Recognition Number
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19-48
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| Standard | |
ANSI IEEE USEMCSC C63.27-2021
American National Standard for Evaluation of Wireless Coexistence |
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Scope/Abstract| 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. |
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| Extent of Recognition
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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. |
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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| FDA recognition of IEEE, ANSI C63.27-2017 [Rec# 19-29] will be superseded by recognition of IEEE, ANSI USEMCSC C63.27-2021 [Rec# 19-48].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. |
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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. |
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| FDA Technical Contacts
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| Standards Development Organizations
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
