| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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055
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Date of Entry 12/21/2020
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FR Recognition Number
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8-551
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| Standard | |
ASTM F2895-20
Standard Practice for Digital Radiography of Cast Metallic Implants |
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Scope/Abstract1.1 This practice covers the procedure for digital radiographic testing of cast metallic surgical implants and related weldments.
1.2 Digital X-ray is an alternative method for radiography of cast metallic surgical implants and related weldments (see Practice F629). |
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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| FDA recognition of ASTM F2895-20 [Rec# 8-551] will be superseded by recognition of ASTM F2895-24 [Rec# 8-642]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 8-551] until December 19, 2027. After this transition period, declarations of conformity to [Rec# 8-551] will not be accepted. |
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Public Law, CFR Citation(s) and Procode(s)*
| Implantable Medical Devices |
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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. |
