We are looking to find the number of tests that have been approved by the FDA over time.

Mary Meekin's Internet report cited that there are over 60,000 CLIA waived laboratory tests (i.e. tests that consumers can use themselves without a doctor) and over 1,000 being added every year. But we are looking for tests that your doctor can order. How many are those and how many are being added per year?

1 Answer 1


They simplest way to get information on the FDA's list of FDA-Approved Home and Lab Tests (which it calls 'In Vitro Diagnostic (IVD) Tests') is to use the following search website:


I believe that you can also find the IVD tests listed in one of the raw download files, but I have not been able to quickly find which database it is. I will try and update this answer when I have time to figure that out.

The underlying data set is updated weekly.

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