Prologue: Prepare for the Future!

In April, the FDA announced their final rule on the regulation of Laboratory Developed Tests. And earlier that same month, Prime Video debuted “Fallout”, the much anticipated series based on the video game franchise of the same name.

Is it merely a coincidence that a show set in a post-apocalyptic wasteland premiers in the same month that the FDA announces its final rule on LDTs? Yes, of course it’s a coincidence. If you think otherwise, you really need to spend a lot less time on the internet.

Mind you, there are some that will see the similarities between the game that my wife will tell you has consumed far too much of her husband’s free time, and the certain armageddon facing LDTs and healthcare in general. I’m going to skirt that debate completely. A quick search of the internet will yield numerous blogs, articles and general rantings both pro and con.

Will the rule be contested in court? Very likely. Does that mean I don’t have to worry about compliance? Possibly. But there are a few labs right now taking the belt and suspenders approach of legal challenges and internal gap assessments. And some of them may be your competitors. 

It’s possible that the courts block implementation, that this drags on for years, and that I am retired long before it’s resolved. It’s also possible that the court allows the FDA to proceed with enforcement while it gets hashed out legally. Heck, it’s even possible that Congress finally acts on VALID.

But in the meantime, to quote a Vault-Tec (see Fallout reference above) salesman, you might want to “prepare for the future”. Just in case the unthinkable happens.

Thus begins a four (five if you count this one) part series of blogs about what you can do to get your LDT ready for the scary world of IVDs, just in case. In upcoming blogs, I will discuss what you need to do first, how to tackle design control, what to do about those unruly RUO manufacturers, and finally some tips on how to analyze and prepare your analytical and clinical data for possible FDA review. And there may just be a Fallout easter egg or two for the devoted fans.

So grab some Radaway, a couple of Stimpaks, and a big bowl of Sugar Bombs, and let’s head off together. Ready? Okie dokie!