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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Recognition 01/30/2014 
FR Recognition Number 14-410
Standard
ASTM F17-13a
Standard Terminology Relating to Flexible Barrier Packaging
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FDA recognition ASTM F17-13a [Rec# 14-410] will be superseded by recognition of ASTM F17-18 [Rec# 14-519].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
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contact
 Patrick Weixel
  FDA/OMPT/CDRH/OIR/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
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