On September 29, 2023, FDA dropped a regulatory change that intends to rapidly bring all LDTs under FDA regulation using the current 510K/PMA models. I wrote a white paper the following week, pointing out that many sources had misquoted the cost to industry as "$5.9B," which FDA published as the "annualized 20 year cost," the full cost being $5.9Bx20 or about $120B. Much of that, $40B, would be due in the first several years. In addition, $40B of regulatory cost would be 40,000 person-years (at $1M/person-year) and 400,000 person years (at $100K/person-year). FDA buried this in table 35 on page 97 of online reference at footnote 34.
I've read the FDA budget (for the whole huge agency) is about $8B in 2023, including user fees (a bit less than half). The IVD proposal would add several billion dollars to FDA labor/work/cost in just a couple years, according to the FDA's own projections. While some of that could be "third party" reviewes, the question then becomes where do you have several billion dollars' worth of IVD-trained regulatory professionals?
And why regulate LDT's newly in 2023/2024, based wholly on what tests were on the market on the morning of May 28, 1976? Sounds nutty on its face.
Adam Bonislawski's Article
I can't quote in detail from an excellent subscription article by Adam Bonislawski at 360Dx, but I am eager to point readers to it. In a nutshell, most of the stakholders that Bonislawski interviewed (including AdvaMed) see the VALID act as preferable. VALID Act is an A-to-Z reboot of FDA's diagnostic laws.
https://www.360dx.com/clinical-lab-management/fda-move-regulate-ldts-mixed-bag-ivd-industry
The article focuses on the current IVD industry, such as AdvaMed, Abbott, etc.
Is there a middle way?
FDA proposed to rapidly dump the whole world of USA LDTs into itself in a couple years, which I rated as simply impossible in my white paper. If that's right, then whatever happens, will be very different that the FDA's September 29 proposal. (As written, the FDA Sept 29 proposal is like a design for a plane that has 10,000 pounds of weight and 1,000 pounds of engine lift. Whatever else happens, you can conclude safely that it won't fly. It doesn't matter whether you like the plane or not.)
The VALID Act is a much-worked-over wholesale revision of FDA law. While there are many short descriptions on the web, I find it hard to read because of the way it inserts and deletes passages of FDA law.
In my white paper, I wondered if there is a middle way. FDA raises two key concerns, LDT accuracy and LDT marketing claims. IF we would requrire "the equivalent of" current New York State rules for LDTs might solve the first problem. As to the marketing claims problem, fpr tjat surely there would be a some creative way to solve that short of a$40 billion dollars and 100,000 man-hour solution.
