Someone asked me today about a benchmark that FDA would launch its regulation of LDT's with a final rule in April 2024. I said the FDA wants to move quickly, during 2024, but whether it's April or October is anybody's guess.
Reading a report from healthcare equities research firm Nephron, they flagged that the official website for the rule launched with an "action data" of April 2024.
https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202310&RIN=0910-AI85
So that's a credible source, and a footnote-able one. Will the LDT rule come out during April? I have no idea, but would tend to be doubtful; I think that April was just as likely chosen as a six-month-placeholder when the draft proposal was filed.
