| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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028
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Date of Entry 03/16/2012
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FR Recognition Number
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12-175
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| Standard | |
ISO 24013 First edition 2006-11-15
Optics and photonics -- Lasers and laser-related equipment - Measurement of phase retardation of optical components for polarized laser radiation |
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Scope/Abstract| This International Standard specifies test methods for the determination of the optical phase retardation of optical components by polarized laser beams. |
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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| FDA recognition of ISO 24013 First edition 2006-11-15 [Rec# 12-175] will be superseded by recognition of ISO 24013 Second edition 2023-06 [Rec# 12-374]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 12-175] until July 2, 2028. After this transition period, declarations of conformity to [Rec# 12-175] 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. |
