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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 048 Date of Entry 12/04/2017 
FR Recognition Number 13-100
Standard
ISO IEC  15459-4 Third edition 2014 Corrected 2016
Information technology - Automatic identification and data capture techniques - Unique identification - Part 4: Individual products and product packages
Scope/Abstract
This part of ISO/IEC 15459 specifies a unique string of characters for the identification of individual products and product packages. The character string is intended to be represented in a linear bar code symbol or two-dimensional symbol or other AIDC media attached to the entity to meet management needs. To address management needs different classes of identities are recognized in the various parts of ISO/IEC 15459, which allows different requirements to be met by the identities associated with each class.

The rules for the identification of an individual occurrence of a product or product package, understood to mean the layers zero and one defined in the International Standards ISO 17367 and ISO 17366, respectively, are defined and supported by examples.
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 801 Subpart B -- Labeling Requirements for Unique Device Identification
21 CFR 830 -- Unique Device Identification
Relevant FDA Guidance and/or Supportive Publications*
Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) - Draft Guidance for Industry and Food and Drug Administration Staff: July 25, 2016.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
 Michael Simpson
  FDA/OC/CDRH/OPEQ/ORP/IO
  301-796-4070
  Michael.Simpson@fda.hhs.gov
Standards Development Organizations
ISO International Organization for Standardization https://www.iso.org/
IEC International Electrotechnical Commission http://www.iec.ch/
FDA Specialty Task Group (STG)
Software/Informatics
*These are provided as examples and others may be applicable.
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