FDA has analyzed this final rule in accordance with the principles set forth in Executive Order 13132.
The following references have been placed on display in the
1. See referenced ISO standards and ISO Technical Committees listed at http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=45332.
2. For information about UPC and other barcodes and GS1, go to http://www.gs1us.org/standards/barcodes.
3. "The Health Industry Bar Code (HIBC) Supplier Labeling Standard," ANSI/HIBC 2.3-2009,
4. "Automatic Identification of Medical Devices,"
5. See record and public comments related to the
7. See discussion of HL7 implementation of SPL model for medical product information at http://wiki.hl7.org/index.php?title=Medical_Product_Information_(SPLr5).
8. Letter from
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