Defining a Globally Unique Device Identifier

Type	Standard / Implementation Specification	Standards Process Maturity	Implementation Maturity	Adoption Level	Federally required	Cost	Test Tool Availability
Standard	Unique Device Identifier as Defined by the Food and Drug Administration at 21 CFR 830.3	Final	Production		Yes	Free	N/A
Implementation Specification	HL7® Cross-Paradigm Implementation Guide: UDI Pattern, Release 2	Final	Production		No	Free	N/A

Limitations, Dependencies, and Preconditions for Consideration	Applicable Security Patterns for Consideration
Per the FDA, Unique Device Identification system will be phased in over several years, with the initial final compliance date of September 24, 2020. In an update published on June 30, 2020, FDA announced a Immediately in Effect Guidance for Industry and Food and Drug Administration Staff, updating its policy regarding compliance dates for class I and unclassified devices that are not implantable, life-supporting, or life-sustaining. The guidance explains that, at this time, the FDA does not intend to enforce UDI labeling (21 CFR 801.20 & 801.50), Direct Mark (21 CFR 801.45), GUDID Data Submission (21 CFR 830.300), and Standard Date Format (21 CFR 801.18) requirements before September 24, 2022. Compliance date for UDI of implantable, life supporting and life sustaining devices was 9/24/2015. These data are available at http://accessgudid.nlm.nih.gov. The HL7 Harmonization Pattern for UDIs is currently in development, with the next revision release anticipated in February 2018.	Feedback requested.

Limitations, Dependencies, and Preconditions for Consideration

Applicable Security Patterns for Consideration

Per the FDA, Unique Device Identification system will be phased in over several years, with the initial final compliance date of September 24, 2020. In an update published on June 30, 2020, FDA announced a Immediately in Effect Guidance for Industry and Food and Drug Administration Staff, updating its policy regarding compliance dates for class I and unclassified devices that are not implantable, life-supporting, or life-sustaining. The guidance explains that, at this time, the FDA does not intend to enforce UDI labeling (21 CFR 801.20 & 801.50), Direct Mark (21 CFR 801.45), GUDID Data Submission (21 CFR 830.300), and Standard Date Format (21 CFR 801.18) requirements before September 24, 2022.
Compliance date for UDI of implantable, life supporting and life sustaining devices was 9/24/2015. These data are available at http://accessgudid.nlm.nih.gov.
The HL7 Harmonization Pattern for UDIs is currently in development, with the next revision release anticipated in February 2018.

Feedback requested.

Comment

Submitted by pwilson@ncpdp.org on 2018-10-01

NCPDP Comment

Support of the UDI-DI will be available in the NCPDP SCRIPT Standard Version 2017071 and the NCPDP Telecommunication Standard Version F2. Today, these numbers are reformatted to support the field size limitations.

Submitted by mkirwan@pchall… on 2017-11-20

New Comment -Section I – U Defining a Globally Unique Device

Please make the following changes:

1.Please add row for “Implementation” and add “IEEE 11073 PHD Harmonization Pattern for Unique Device Identifiers”. The remaining fields are the same as for HL7 Harmonization…

Submitted by pwilson@ncpdp.org on 2017-11-20

NCPDP - Comment

Add the following:

Type-Implementation Specification

Standard Implementation/Specification- NCPDP Product Identifiers Standard Implementation Guide Version 1.4

Standards Process Maturity – Final

Implementation Maturity- Production

Adoption Level – 3

Federally Required – No

Cost – $

Test Tool Availability – No

Submitted by Albert Taylor on 2017-12-12

NCPDP Product Identifiers Standard IG recommendation

Thank you for your comment. Can you please provide additional information about this IG, including a link to the actual IG for reference and information?

Submitted by pwilson@ncpdp.org on 2018-10-01

NCPDP Response

The NCPDP Product Identifiers Standard Implementation Guide is intended to define, clarify, and ensure continuity of the Product Identification Codes for drugs and other items used in the healthcare marketplace to meet the needs within the healthcare industry including but not limited to payers, providers and patients. You must be an NCPDP member to access the standards.

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