Comment from Anonymous
AnonymousSupportIndividual
Summary: An individual working in the development of in vitro diagnostics (IVDs) supports the reclassification of Tuberculosis tests from Class III to Class II. They argue that the current Class III requirements are too costly and that a Class II designation will better encourage industry innovation to meet the growing need for TB testing.
As an individual working on developing IVDs, including Tuberculosis tests, this reclassification is a welcome step as it will encourage innovation from the industry, as Class III devices are extremely costly to register and maintain the registration, while a Class II designation can still ensure safe and effective devices are marketed. As Tuberculosis tests can be difficult to administer and run - many are manual or take significant run time - new and additional tests are necessary to tackle the growing need for TB testing.