| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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062
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Date of Entry 05/29/2024
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FR Recognition Number
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12-361
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| Standard | |
ICDM IDMS Version 1.2 May 2023
Information Display Measurements Standard |
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Scope/Abstract| The IDMS specifies standard measurement procedures, test patterns, measurement report templates, and testing software to quantify electronic display characteristics and qualities. The document is applicable to various types of displays including non-see-through (virtual reality) and see-through type (augmented reality) eyewear displays. |
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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| FDA recognition of ICDM IDMS Version 1.2 May 2023 [Rec# 12-361] will be superseded by recognition of ICDM IDMS Version 1.3 May 31 2025 [Rec# 12-384]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-361] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 12-361] will not be accepted. |
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Relevant FDA Guidance and/or Supportive Publications*
| 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 Organization
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| FDA Specialty Task Group (STG)
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| *These are provided as examples and others may be applicable. |
