Lab Developed Test Regulations

The APHL Public Policy Program has been monitoring FDA Lab Developed Test Regulations and has prepared summaries and analysis on its APHL webpage: https://www.aphl.org/policy/Pages/LDT-members.aspx .

FDA Universal Device Identifiers (UDIs)

FDA issued proposed changes to In Vitro Diagnostics validation in January 2025. Public comments are due Mar 10, 2025. While the rule and its changes do not have an immediate impact on data standards or data exchange, the APHL Informatics team has asked the APHL Public Policy Program to submit one informatics-themed comments as part of their larger package of feedback in March. See below for details.

APHL Informatics Comment

We encourage FDA to request that all data required for the evaluation of IVDs that will end up in the publicly available documentation like package inserts be submitted in a structured format. Ideally the universal device identifier(s) for the test (and instrument, if applicable) should also be included in the submission. While having data available in a structured electronic format is helpful in itself, once the Laboratory Interoperability Data Registry (LIDR) goes live, the IVD information can be more easily incorporated into the Registry if it is in a standardized electronic format.

LIDR is a key outcome of the Systemic Harmonization and Interoperability Enhancement for Laboratory Data (SHIELD). SHIELD is an FDA-sponsored public-private initiative to develop and launch collaborative policies and business models to overcome laboratory interoperability barriers. SHIELD’s goal is realized when a specific laboratory test result from one In-Vitro Diagnostic (IVD) platform and the same laboratory test performed on a another IVD platform can be considered equivalent and can be safely intermingled to achieve complete clinical interoperability. A more limited, but necessary, use of laboratory data occurs when laboratory test data performed on a particular IVD platform can be associated electronically with laboratory test data performed on the same IVD platform at any healthcare institution, which is referred to as structural interoperability.

LIDR is envisioned as a centralized repository of codes serving as an easily accessible authoritative source for the standardized digital representation of laboratory test results. It is hoped that LIDR will not only provide a standardized means to store, search and access data about unique laboratory test results needed for semantic interoperability, but allow automated export of the data standards for use in healthcare information technology, such as the Laboratory Information System (LIS), Laboratory Information Management System (LIMS) and Electronic Health Record (EHR). The LIVD format allows test manufacturers to provided standardized test data, which can be used to standardize data input into LIDR. LIDR will have support for additional data elements beyond those in the LIVD file format. LIVD could also be used as a standardized format to share the code mappings expected to be used in data exchanges. This standardization will reduce the burden on individuals mapping laboratory data elements.

FDA should ensure that the information generated from the evaluation of IVDs can feed into this ecosystem, and we encourage FDA to work with standards and interoperability experts to determine a structured format that will facilitate interoperable data exchange across regulatory and healthcare systems.