The EUA guidelines for COVID-19 diagnostic tests are very reduced compared to a normal 510(k) process; many 510(k) elements are not required. The agency (FDA) wants to know your intent to market.
You can do a pre-EUA to give the FDA information as to what and how the product is going to work. And they’ll give you some guidance on the data they’ll want to see. Then, you can submit a final EUA requesting the agency to authorize your product for sale during this emergency.
The agency can cancel that EUA at any time, and then you cannot sell unless you get a 510(k). However, the agency has said that they see this emergency use being in place for quite a long time — much longer than others we have seen.
Requirements are minimal. There are product performance requirements specific to limit of detection (LOD), cross-reactivity and performance with spiked samples.
The agency’s getting closer to asking you to test some real samples. Initially, you couldn’t get your hands on any real samples, but the samples are becoming available, with more testing that’s done. So, the FDA wants to see that.
Things such as software validation, process validation, and other information specific to a 510(k) are not required.