At Linked In, Karin Hughes is one of the first to report that Executive Order #12866 will be used to reverse the FDA LDT rule. It will formally retract the FDA LDT rule, which lost in federal court in Texas back in May 2025.
It looks to me like the document was "received August 6" but may be in regulatory review, it may be titled but not released. It will be interesting if it just briefly retracts the LDT rule or if it elaborates on a new agency direction.
https://www.reginfo.gov/public/do/eoDetails?rrid=1044563
The title is, Medical Devices; Laboratory Developed Tests; Rescission, and the status seems to be "pending."
The "meetings" tab shows no related meetings.
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EO12866 is not new; it represents a 1993 regulatory framework. The new document would, I think, be a new document or rule issued under the authority of 12866. I think FDA Law Blog also indicates the rule is written but under review as of August 11.
https://www.reginfo.gov/public/jsp/EO/eoDashboard.myjsp
