| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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11-264
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| Standard | |
ASTM F1820-13
Standard Test Method for Determining the Forces for Disassembly of Modular Acetabular Devices |
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Scope/Abstract| 1.1 This test method covers a standard methodology by which to measure the attachment strength between the modular acetabular shell and liner. Although the methodology described does not replicate physiological loading conditions, it has been described as a means of comparing the integrity of various locking mechanisms. |
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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| FDA recognition of ASTM F1820-13 [Rec# 11-264] will be superseded by recognition of ASTM F1820-22 [Rec# 11-394]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 11-264] until December 17, 2023. After this transition period, declarations of conformity to [Rec# 11-264] 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. |
