| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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050
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Date of Entry 09/17/2018
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FR Recognition Number
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8-476
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| Standard | |
ASTM F2004-17
Standard Test Method for Transformation Temperature of Nickel-Titanium Alloys by Thermal Analysis |
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Scope/Abstract| This test method defines procedures for determining the transformation temperatures of nickel-titanium shape memory alloys, produced in accordance with Specification F2063, by differential scanning calorimetry. |
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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| FDA recognition of ASTM F2004-17 [Rec# 8-476] will be superseded by recognition of ASTM F2004-24 [Rec# 8-622]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-476] until December 20, 2026. After this transition period, declarations of conformity to [Rec# 8-476] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
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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. |
