As we track the progress of FDA decisions to regulate lab developed tests on a staged basis (2025-2027), two important side bars are these. First, how is similar regulatory change faring in Europe, which is a few years of the FDA regarding Euro-LDTs. Second, how will the roll-in of FDA regulatory controls affect the burgeoning use of AI in LDTs?
For an open-access article on the ramping-up use of AI in pathology at Mayo Clinic, see CAP TODAY, July 2024.
https://www.captodayonline.com/mayo-pathologists-create-and-test-their-own-ai-algorithms/
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There are also two important articles over a 360Dx, both for subscribers.
In the first, Justin Petrone looks at the "bumpy ride" that labs and small firms are having under rising EU regulations. The EU IVDR regulations include some safe harbors for tests used in a health system for an unmet need - something the FDA borrowed without much acknowledgment for its own LDT program. However, it's a "bumpy ride" in Europe and a worthwhile for predictioneers in the US.
https://www.360dx.com/business-news/eu-ivdr-transition-remains-bumpy-ride-smaller-firms-labs
The Euro term for LDT is "IHD, In House Devices"
Here's a very brief condensation of some of Petrone's points; see the full article. [My notes, not a direct quote] The European Union's In Vitro Diagnostic Regulation (IVDR) has been a significant point of contention for smaller firms and laboratories. The IVDR has been marked by delays, cost increases, and a notable drop-off in certification applications. The European Commission has extended deadlines for various IVD classes, due to the complexities and uncertainties in compliance.
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Second, and complementary to the open access Mayo article above, Greg Cima looks at the coming battle between regulation and innovation in the AI-pathology space. It's worth close reading.
Cima notes that Scott Gottlieb has recently advocated in JAMA for new medical AI regulation, to avoid the creaky "PMA or 510(k)" system which is approaching 50 years old See next section.
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Extra credit question.
See Scott Gottlieb's July 2024 article in JAMA FORUM that "Congress must update FDA regulations for medical AI." Entry point here.
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| Petrone / EU IVDR |
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| Cima / Labs, AI, regulation |
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| Cima, AI, but in oil painting style |
