From the FDA23 Oct 2024 08:52
“ The FDA has also included additional enforcement discretion policies, such as for LDTs approved by the New York State’s Clinical Laboratory Evaluation Program (CLEP), as described in the preamble to the final rule, where that program’s review of analytical and clinical validity helps to mitigate the risk of harm from inaccurate and unreliable LDTs. ”
That’s the nub, imho.