Saturday, March 2, 2024

NOTEWORTHY: FDA Sends Final LDT Rule to White House

Header: FDA Sends Finalized LDT Rule to White House OMB/OIRA


Moving at a fast pace, FDA has finalized its review of comments on the LDT regulation, and the final regulation was logged at the White House on March 1, 2024.   Specifically, the rule is at the Office of Management and Budget (OMB) in the Office of Information and Regulatory Affairs (OIRA).

OIRA Meetings

The OIRA page logs all official meetings on the rule, called EO-12866 meetings.  Find them here:

Nine meetings were logged, the first on August 4 (Cara Tenenbaum and Center for Science in the Public Interest, which submitted a 4-page letter demanding LDT regulation in May 2023).  (See also ProPublica June 14). 

The last one was September 26 (William Signer of Carmen Group and ACELT, Academic Coalition for Effecitve Laboratory Tests). ACELT brought speakers from U Chicago, U Colorado, Harvard, Yale, and Wash U. Each of the meetings shows cloud copies of any documents presented. For example, ACELT included a 25-page legal memo against the FDA's authority to regulate LDTs.


The rule's page when it was a draft rule is here.


Update.  As of 3/18, OMB had scheduled5 new meetings:

3/18, Assoc for Dx and Lab Med
3/19, AMP
3/20, ARUP
3/21, ACMG
3/22, Childrens Hospital Association