For many years, one of the most controversial topics in device regulation has been the dual-track oversight of in vitro diagnostics (IVDs) and laboratory developed tests (LDTs). Distributed IVD products are regulated by FDA, while laboratories that perform LDTs are regulated by the Centers for …
From the start of the COVID-19 pandemic, access to accurate and reliable testing to identify patients exposed to SARS-CoV-2 or infected with COVID-19 was identified as a critical element of an effective public health response. Testing is needed to diagnose individuals with active symptoms, enable …
In a jaw-dropping move, HHS announced today that, effective immediately, FDA will no longer require premarket review of laboratory developed tests (LDTs)—including LDTs to detect the virus that causes COVID-19—absent notice and comment rulemaking. HHS is rescinding all guidance documents and informal statements of policy concerning …
FDA is exercising significant emergency authorities during the COVID‑19 pandemic. Not all of industry is affected, but those who are manufacturing or distributing (or using) devices being used to fight the pandemic can benefit by understanding FDA’s emergency‑related policies and practices. These are evolving every …
Last week, FDA once again changed course in its approach towards regulating pharmacogenomic (PGx) tests. We have blogged on this story several times before (see past blog posts here and here). A brief recap follows. On October 31, 2018, FDA issued a Safety Communication regarding PGx …
Over the years, we have blogged many times on FDA’s approach towards laboratory-developed tests (LDTs) (see, e.g., prior posts here, here, here, here, and here). On October 31, 2018, FDA issued a Safety Communication relating to one particular type of LDT: pharmacogenomic (PGx) assays. On …
