Monday, January 22, 2024

FDA Regulation of LDT's: Stated April 2024 Date

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.

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.