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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 14-519
ASTM F17-18 Standard Terminology Relating to Flexible Barrier Packaging
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.
Extent of Recognition
Complete standard
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.
Transition Period
FDA recognition ASTM F17-13a [Rec# 14-410] will be superseded by recognition of ASTM F17-18 [Rec# 14-519]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 14-410] until December 28, 2019. After this transition period, declarations of conformity to [Rec# 14-410] will not be accepted.
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
FDA Technical Contact
 Patrick Weixel
  FDA/OC/CDRH/OPEQ/OIDRH/DRH/
  301-796-5537
  Patrick.Weixel@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
Sterility
*These are provided as examples and others may be applicable.
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