Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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053
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Date of Entry 12/23/2019
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FR Recognition Number
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8-519
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Standard | |
ISO 13782 Second edition 2019-04 Implants for surgery - Metallic materials - Unalloyed tantalum for surgical implant applications |
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Scope/AbstractThis document specifies the characteristics of, and corresponding test methods for, unalloyed tantalum sheet, rod and wire used in the manufacture of surgical implants. NOTE 1 Provision is made for two grades of tantalum. |
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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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Public Law, CFR Citation(s) and Procode(s)*
21 CFR 888.3XXX Metallic components of all implantables |
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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. |