Singapore Drafts New Guidelines On Lab-Developed Tests (LDTs)

Last month, Singapore’s HSA provided a draft guideline on LDTs. This guideline stated that LDTs used as IVDs or for RUO are not classified as LDTs. LDTs are tests that are only developed and used by labs at their own sites. Labs that develop LDTs are licensed under the Singapore HSA. LDTs must meet relevant quality management systems as well as post-market requirements.