FDA's LDT Regulation Rule Heads to Final Stage in April
The Office of Information and Regulatory Affairs (OIRA) has received the final version of the U.S. Food and Drug Administration's (FDA) regulation rule for Laboratory Developed Tests (LDTs) on March 1, 2024. This follows an expedited review process and sets the stage for a significant hearing and potential rule issuance in April.
The final rule was submitted to OIRA after less than 5 months from the proposed rule's publication and less than 3 months following the end of the public comment period. This swift progress indicates the importance and urgency of the LDT regulation.
OIRA has scheduled a series of meetings with stakeholders for the week of March 18th, hinting at a possible April 2024 release of the final rule. Meanwhile, the House Energy and Commerce Committee's Health Subcommittee has arranged a hearing titled 'Evaluating Approaches to Diagnostic Test Regulation and the Impact of the FDA’s Proposed Rule' for March 21, 2024. However, the specific speaker or organisation for this event has not been publicly disclosed.
The final LDT regulation rule is expected to be issued soon, following OIRA's review and stakeholder consultations. The upcoming hearing will provide insights into the regulation's impact and the FDA's proposed rule. The swift progress through the review process underscores the significance of this regulation for the healthcare industry.
