Distribution of LOINC Codes for In Vitro Diagnostic Tests by Manufacturers
This guidance addresses the distribution of LOINC codes by IVD test manufacturers to users (clinical laboratories and software vendors). It specifically focuses on the appropriate use of LOINC codes for IVD tests, excluding test results coding for interoperability and UDI requirements.
What You Need to Know? 👇
What is LOINC and why is it important for IVD manufacturers?
LOINC (Logical Observation Identifiers Names and Codes) is a standardized coding system that provides unique numeric codes for laboratory tests. It’s crucial for semantic interoperability in electronic health records, enabling consistent data exchange across healthcare systems and supporting decision support tools.
Is LOINC coding mandatory for FDA-regulated IVD devices?
No, LOINC coding is voluntary and not required by FDA. However, FDA strongly encourages the use of consensus standards like LOINC for coding IVD tests to promote interoperability and consistent representation of laboratory data across healthcare systems.
Can manufacturers include LOINC codes in their device labeling?
Yes, FDA supports voluntary inclusion of LOINC codes in device labeling if the information is accurate and consistent with approved or cleared indications. Manufacturers can include codes directly in printed labeling or reference external locations like websites containing LOINC tables.
What are the risks of providing LOINC codes for off-label uses?
Providing LOINC codes for uncleared or unapproved indications may be considered evidence of new intended use, potentially resulting in the device being considered adulterated or misbranded. However, responding to unsolicited requests for specific LOINC codes is generally acceptable.
Does FDA recommend a specific format for distributing LOINC codes?
No specific format is required, but FDA strongly encourages using FDA-recognized consensus standards like the LOINC transmission document for IVDs (LIVD) standard. This facilitates laboratories’ ability to adopt new codes and maintain databases for local use.
How does LOINC differ from Unique Device Identifiers (UDI)?
LOINC codes identify the type of laboratory test being performed, while UDI identifies a specific model/version of a regulated device from a specific manufacturer. These serve different purposes and LOINC guidance doesn’t affect UDI requirements for regulated devices.
What You Need to Do 👇
Recommended Actions
- Review current labeling practices and determine if including LOINC codes would be beneficial
- If including LOINC codes:
- Ensure codes match approved/cleared indications
- Consider using standardized formats for code distribution
- Implement quality system controls if codes are incorporated into device output
- Establish process for handling individual requests for LOINC codes for uncleared/unapproved uses
- Monitor developments in LOINC transmission standards
- Consider implementing FDA-recognized consensus standards for LOINC code communication
- Document any LOINC code distribution methods and maintain accuracy of provided codes
Key Considerations
Labelling
- LOINC codes can be voluntarily included in device labeling if accurate and consistent with approved/cleared indications
- Manufacturers can include LOINC codes in printed labeling or reference to external location
- LOINC codes should be consistent with FDA-cleared or FDA-approved Indications for Use
Software
- LOINC codes incorporated directly into devices may be subject to quality system requirements
- No specific format required for distributing LOINC codes
- Standardized formats (JSON, XML) are acceptable for code distribution
Other considerations
- LOINC coding is voluntary and not required by FDA
- Individual, unsolicited requests for LOINC codes for uncleared/unapproved uses can be addressed without being considered evidence of promoting off-label use
- Use of FDA-recognized consensus standards is strongly encouraged for communicating LOINC codes
Relevant Guidances 🔗
- Research Use Only and Investigational Use Only In Vitro Diagnostic Products - Labeling and Distribution Requirements
- In Vitro Diagnostic Device Studies Exempt from Investigational Device Exemption Requirements
- Unique Device Identifier (UDI) Form and Content Requirements
- Content of Premarket Submissions for Device Software Functions
Related references and norms 📂
- LIVD: LOINC transmission document for IVDs standard
Original guidance
- Distribution of LOINC Codes for In Vitro Diagnostic Tests by Manufacturers
- HTML / PDF
- Issue date: 2018-06-15
- Last changed date: 2019-02-09
- Status: FINAL
- Official FDA topics: Medical Devices, Laboratory Tests, Digital Health, Labeling, IVDs (In Vitro Diagnostic Devices), Biologics
- ReguVirta ID: 81afdfd4059968b97bbaec27236ca3a7