| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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064
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Date of Entry 05/26/2025
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FR Recognition Number
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12-372
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| Standard | |
ISO 14880-3 Second edition 2024-11
Optics and photonics -- Microlens arrays -- Part 3: Test methods for optical properties other than wavefront aberrations |
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Scope/Abstract| This document specifies methods for testing optical properties, other than wavefront aberrations of microlenses in microlens arrays. It is applicable to microlens arrays with very small lenses formed on one or more surfaces of a common substrate and to graded-index microlenses. |
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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| FDA recognition of ISO 14880-3:2006 [Rec# 12-172] will be superseded by recognition of ISO 14880-3 Second edition 2024-11 [Rec# 12-372]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-172] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 12-172] 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 Contact
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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. |
