One of the interesting parts of the proposal to regulate LDTs via the FDA medical device manufacturing laws, is the degree of overlap with CLIA.
It's not just a little, it's a lot, and quickly each aspect of the overlap becomes painfully complex.
For a guide, see the curretly free 120 page guide to FDA QSR for LDTs (quality system regulations for lab developed tests) issued in September 2024 by CLSI, the Clinical Lab Standards Institute.
Access it here:
https://clsi.org/standards/products/quality-management-systems/documents/qsrldt/
Learn for example what it means to track vender records, supply quality, and reagent validation under FDA vs CLIA. Dive into the FDA labeling recommendations, which are new and complex for LDTs and have an iron grip on promotional claims and remarks as well.
