This is required language by the FDA.
Outside of any “state of emergency”, in normal testing scenarios, there are generally 2 main types of tests done. You have diagnostic testing and then you have everything else. Items in that everything else category includes things like DNA testing for research-based projects to heritage or allergy tests. When you are not attempting to diagnose a health-related issue the FDA considers it more of a consumer-based product and optional, not placing or mandating any specific regulations.
On the flip side, when you are performing a diagnostic test, of any type there are very strict and enforced FDA regulations and compliance requirements to ensure the population’s safety the best it can. In this case, it would mean seeing the text “FDA Approved”. In order for a product to earn this seal of approval, it undergoes a minimum of an 18-month validation process proving its value, benefits, and safety. This category has many different “Classes” or types.
In a state of emergency like we are in, the FDA uses the very specific word “Authorized” in place of “Approved”. This means that the device or product passed an abbreviated version of the “approval” process in order to be quickly integrated into usage for the benefit of the larger good it will provide. At Spectrum, we have one saliva collection device for each of the two testing category types. The SDNA-1000 and the SDNA-2000. The SDNA-2000 is currently in the validation process for FDA Approval. Because of the pandemic, applications for FDA 510k approval are placed behind the FDA’s priority of issuing validated authorizations. This is in part because, in this state of emergency, a device EUA authorization is seen as a temporary equivalent. Spectrum’s device EUA (202432) for the SDNA-1000 can be found on and downloaded from the FDA’s website.