HSA Medical Device Cluster (MDC) released a regulatory draft guideline covering Laboratory Developed Tests (LDTs). The goal of the upcoming regulation is to harmonize regulatory control for clinical laboratories in accordance with the Healthcare Services Act (HCSA) and current regulatory practices that are applicable to IVDs and laboratories under the HCSA.
In addition to key definitions and scope of the guidance, the draft document will provide an overview on the LDT Regulatory Controls covering Product Controls, Manufacturing Quality Controls, and Post-Market Controls. The HSA has extended out an invitation to all stakeholders to provide feedback on the following document from July 12 to August 12, 2022:
[For Consult] Regulatory Guidelines for Laboratory Developed Tests (LDTs)
Consultation on Regulatory Guidelines for Laboratory Developed Tests (LDTs)