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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 062 Date of Entry 05/29/2024 
FR Recognition Number 5-142
Standard
ISO  780 Fifth edition 2015-12-01
Packaging - Distribution packaging - Graphical symbols for handling and storage of packages
Scope/Abstract
This International Standard specifies a set of graphical symbols conventionally used for marking of distribution packages in their physical distribution chain to convey handling instructions. The graphical symbols should be used only when necessary.

This International Standard is applicable to packages containing any kind of goods, but does not include instructions specific to handling of dangerous goods.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
21 CFR Part 801 Labeling, medical devices, reporting and recordkeeping requirements
21 CFR Part 660 Biologics, labeling, reporting and recordkeeping requirements
21 CFR Part 809 Labeling, medical devices
Relevant FDA Guidance and/or Supportive Publications*
Final Rule: Use of Symbols in Labeling, Issued June 15, 2016

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Staci Stoller
  CDRH/OST/ORR/DSCA
  301-837-7173
  staci.stoller@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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