Representing Unique Implantable Device Identifiers

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
Standard	NCPDP® Telecommunication Standard Implementation Guide, Version F2	Final	Production	Feedback Requested	No	$
Standard	NCPDP SCRIPT Standard, Implementation Guide, Version 2017071	Final	Production	Feedback Requested	No	$	Yes
Implementation Specification	HL7® Cross-Paradigm Implementation Guide: UDI Pattern, Release 2	Final	Production		No	Free	N/A
Implementation Specification	NCPDP Product Identifiers Standard Implementation Guide Version 1.4	Final	Production	Feedback Requested	No	$	No
Emerging Implementation Specification	HL7 FHIR® US Core Implantable Device Profile	In Development	Feedback requested	Feedback Requested	No	Free	No
Emerging Implementation Specification	HL7 CDA® R2 Implementation Guide: C-CDA Supplemental Templates for Unique Device Identifier (UDI) for Implantable Medical Devices, Release 1 - US Realm	Balloted Draft	Production	Feedback Requested	No	Free
Implementation Specification	NCPDP SCRIPT Standard, Implementation Guide, Version 2023011	Final	Feedback requested	Feedback Requested	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. HL7 Cross-Paradigm Implementation Guide: UDI Pattern, Release 1 - will be updated with HL7 FHIR Releases.	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.
HL7 Cross-Paradigm Implementation Guide: UDI Pattern, Release 1 - will be updated with HL7 FHIR Releases.

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