Transmitting a 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
Implementation Specification	NCPDP Telecommunication Standard, Implementation Guide, Version F6	Final	Pilot	Feedback Requested	No	$	No
Implementation Specification	NCPDP SCRIPT Standard, Implementation Guide, Version 2023011	Final	Pilot		Yes	$	No

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. Support of the full length of the UDI-DI will be available in the NCPDP SCRIPT Standard Implementation Guide, Version 2017071, and the NCPDP Telecommunication Standard Implementation Guide, Version F6. Today, these numbers are reformatted to support the field size limitations.	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.
Support of the full length of the UDI-DI will be available in the NCPDP SCRIPT Standard Implementation Guide, Version 2017071, and the NCPDP Telecommunication Standard Implementation Guide, Version F6. Today, these numbers are reformatted to support the field size limitations.

Feedback requested.

Comment

Submitted by pwilson@ncpdp.org on 2024-08-13

NCPDP Comment

NCPDP recommends that ASTP/ONC add the following:

Type- Implementation Specification

Standard Implementation/Specification- NCPDP SCRIPT Standard, Implementation Guide, Version 2023011

Standards Process Maturity – Final

Implementation Maturity- Pilot

Adoption Level – 1

Federally Required – Yes

Cost – $

Test Tool Availability – No

NCPDP recommends removing NCPDP SCRIPT Standard, Implementation Guide, Version 2022011, as NCPDP SCRIPT Standard Implementation Guide, Version 2023011 is the next version named by ASTP/ONC and Medicare. Federally required should be changed to a Yes for the NCPDP SCRIPT Standard Implementation Guide, Version 2023011.

Submitted by pwilson@ncpdp.org on 2023-10-06

NCPDP Comment

NCPDP recommends that ONC add the following:

Type- Implementation Specification

Standard Implementation/Specification- NCPDP SCRIPT Standard, Implementation Guide, Version 2022011

Standards Process Maturity – Final

Implementation Maturity- Pilot

Adoption Level – 1

Federally Required – No

Cost – $

Test Tool Availability – No

Submitted by shellyspiro on 2023-10-02

Pharmacy HIT Collaborative (PHIT) comment

PHIT supports NCPDP’s recommendation of adding NCPDP SCRIPT Standard, Implementation Guide, Version 2022011 to the implementation specification.

Submitted by pwilson@ncpdp.org on 2021-09-29

NCPDP Comments

Update: NCPDP Telecommunication Standard, Implementation Guide, Version F6 is not in production. It is a published version. We are waiting for CMS to name this version in HIPAA. No date for production is available at this time. Adoption Level should be “Feedback Requested”.
Add the following:

Type-Implementation Specification

Standard Implementation/Specification- NCPDP SCRIPT Standard, Implementation Guide, Version 2017071

Standards Process Maturity – Final

Implementation Maturity- Production

Adoption Level – 5

Federally Required – Yes

Cost – $

Test Tool Availability – Yes

Test Tool Link: https://tools.ncpdp.org/erx/#/home

Support of the full length of the UDI-DI will be available in the NCPDP SCRIPT Standard Implementation Guide, Version 2017071, and the NCPDP Telecommunication Standard Implementation Guide, Version F6. Today, these numbers are reformatted to support the field size limitations.

Submitted by pwilson@ncpdp.org on 2020-11-07

NCPDP Comment

Add the following:

Type-Implementation Specification

Standard Implementation/Specification- NCPDP SCRIPT Standard, Implementation Guide, Version 2017071

Standards Process Maturity – Final

Implementation Maturity- Production

Adoption Level – 1

Federally Required – No

Cost – $

Test Tool Availability – Yes

Test Tool Link: https://tools.ncpdp.org/erx/#/home

Support of the full length of the UDI-DI will be available in the NCPDP SCRIPT Standard Implementation Guide, Version 2017071, and the NCPDP Telecommunication Standard Implementation Guide, Version F6. Today, these numbers are reformatted to support the field size limitations.
Add the following:

Type-Implementation Specification

Standard Implementation/Specification- NCPDP Telecommunication Standard, Implementation Guide, Version F6

Standards Process Maturity – Final

Implementation Maturity- Production

Adoption Level – 1

Federally Required – No

Cost – $

Test Tool Availability – No

Submitted by pwilson@ncpdp.org on 2019-09-23

NCPDP Comment

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

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 dvreeman on 2018-09-27

Regenstrief - Comment

This interoperability need corresponds to a syntax standard, not a terminology standard. As such, it should be moved to the Content/Structure Standards and Implementation Specifications section.

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