| 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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14-554
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| Standard | |
ASTM F17-20
Standard Terminology Relating to Flexible Barrier Packaging |
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Scope/Abstract| 1.1 This terminology covers the principal terms relating to primary barrier packaging and its materials. This terminology contains related definitions and descriptions of terms used or likely to be used in primary barrier packaging standards. The purpose of terminology is to promote clear understanding and interpretation of the standards in which they are used. |
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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)*
| This standard is relevant for all medical devices where terminology relating to barrier materials for medical packaging is a component of the development and manufacture of the product |
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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. |
