Laboratory Developed Tests (LDTs) are in vitro diagnostic tests (IVDs) that are:
• developed and manufactured within a licensed clinical laboratory and solely for use within the same laboratory where it was developed, and
• intended for specific clinical diagnostic use
While commercial IVDs have already been subjected to regulatory controls under the Health Products Acct (HPA), LDTs have not been regulated by HSA. Regulating LDTs under the HPA is necessary to ensure that these diagnostic tests meet the essential standards of manufacturing quality and efficacy and provide accurate results for patients.”
“HSA’s new guideline GL-08: Regulatory Guidelines for Laboratory Developed Tests (LDTs), is applicable to all LDTs (i.e. products including test reagents, and kits) developed within a licensed clinical laboratory solely for use within the same laboratory. This does not include test reagents and kits developed within a licensed clinical laboratory and distributed outside of the laboratory where it was developed as these will be regulated as commercial IVD products by HSA.
An overview of the regulatory controls for LDTs can be divided into three broad categories:
1. Product Controls:
LDTs are not subject to product evaluation and registration by HSA. However, clinical laboratories are able to notify the list of LDTs they implement and use in their laboratory at MOH’s licensing portal, Healthcare Application and Licensing Portal.
Clinical laboratories are responsible for the validation and implementation of these tests in their facilities and are required to ensure that their LDT continues to be safe and effective for clinical use. In doing so, laboratories are required to systematically document specific prescribed information regarding their LDT in an Objective Checklist, update this periodically and maintain it on file within their facility, and shall be submitted for review when required by HSA.
2. Manufacturing Quality Controls
Clinical laboratories that develop and use LDTs for clinical diagnostic purposes are manufacturers. Hence, they are required to implement and maintain an appropriate quality management system in their facilities in relation to their manufacturing activities.
3. Post-market Controls
Post-market requirements are applicable to clinical laboratories that manufacture LDTs. This includes reporting of Adverse Events and Field Safety Corrective Actions, including recalls, associated with the use of the LDT to HSA. When AEs and FSCAs are reported, HSA will monitor the progress of the investigations conducted by the laboratory on the issue identified. HSA will review the proposed follow-up measures and corrective/preventive actions, including the corresponding validation studies conducted to ensure that these are adequate and appropriate to ensure the quality, safety and efficacy of the LDT by the laboratory.
For more details on the regulatory controls, please refer to GL-08: Regulatory Guidelines for Laboratory Developed Tests (LDTs).
(GL-08 weblink: https://www.hsa.gov.sg/docs/default-source/hprg-mdb/guidance-documents-for-medical-devices/gl-08-r1-regulatory-guidelines-for-laboratory-developed-tests-(ldts)-(2023-mar)-pub.pdf)