Singapore's Health Sciences Authority (HSA) has issued draft guidelines on Laboratory Developed Tests (LDTs) from 12 July 2022 until 12 August 2022. The response received from the industry will be calibrated together with the existing regulations on commercial in-vitro diagnosis (IVD) in order to document a mutual understanding and provide new regulatory guidance specifically for laboratory developed tests (LDTs).
As defined in the guidance, LDTs are in-vitro diagnostic tests (IVDs) that are developed within licensed clinical laboratories and solely for use within the same laboratories and specifically for clinical diagnostic use. The guidance will be used to assist clinical laboratories in understanding regulatory requirements for LDTs that are authorized under the Health Products Act 2007 (HPA) and the Health Products (Medical Devices) Regulations 2010 (HP (MD) Regulations). LDTs activities are not regulated under HSA, however, it is subjected to HPA regulations for maintaining the manufacturing quality, efficacy and accuracy.
-Product Controls
Though LDTs are not regulated under HSA, related clinical laboratories must submit an annual notification list of developed LDTs within the laboratories. The notification can be submitted via the Healthcare Application and Licensing Portal (HALP).
Besides, clinical laboratories is accountable for documenting prescribed information related to the LDTs performed through an Objective Checklist. The checklist should also include the purpose of developing LDTs instead of commercial IVDs, the performance evaluation results, the LDTs design, analytical and clinical validity evaluation of the LDTs and also verification control methods used for the accuracy of the clinical result.
The Objective Checklist should be approved by the Laboratory Quality Assurance Manager, up-to-date and ready for HSA review if requested.
-Manufacturing Quality Controls
The quality management system is a standard requirement for manufacturers to maintain the quality and performance specifications of LDTs developed within the laboratories. There are 3 relevant manufacturing quality standards that can be complied with by the clinical laboratories:
Singapore Accreditation Council Certification (SAC) for ISO 13485: Medical devices – Quality management systems – Requirement for regulatory purposes
Singapore Accreditation Council (SAC) laboratory accredited based on ISO 15189: Medical laboratories – Requirements for quality and competence
Other relevant laboratory accreditation programs for LDT
Clinical laboratories are also required to comply with HP (MD) Regulations by supervising the safety and performance of LDTs and preparing additional measures, documenting the development and clinical use of LDTs within the facility and documenting any issues or feedback and implementing corrective actions.
Further, clinical laboratories must ensure every development process is taken care of in order to produce a good quality management system. Every development process should be documented including the raw materials used in the activities, maintenance management for equipment involved in the LDTs and the production of each LDT batch within the facility. Besides, the staff and laboratory professionals involved in the LDTs should be verified and professionally trained to perform accurate LDTs.
-Post-market Controls
The requirements for post-market controls are reporting Adverse Events (AE) and Field Safety Corrective Actions (FSCAs) including recalls. The Laboratory Quality Assurance Manager or Clinical Governance Officer (CGO) is the responsible person reporting for any of the stated events that happened and affected LDTs to the HSA.
Adverse Events (AE) occur in the context of defect issues or any concerns related to the AE that comes from LDTs activities, for instance, inaccurate results or inappropriate treatment. While for FSCA, the clinical laboratories should consider initiating the actions if there is any possible quality of performance issue from the LDTs. There are some cases of AE reports that might require FSCA to alleviate the identified risks. Reporting timelines for both AE and FSCA can be referred to here.
Source: HSA
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