Federal Register #CMS-3485-NC

RFI: Input Sought on Updates to CLIA Laboratory Regulations

This opportunity is a Request for Information (RFI) from the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC), both under the Department of Health and Human Services, seeking input on potential updates to the Clinical Laboratory Improvement Amendments (CLIA) regulations. - Government Buyer: - Department of Health and Human Services (HHS) - Centers for Medicare & Medicaid Services (CMS) - Centers for Disease Control and Prevention (CDC) - No specific OEMs or vendors are named in this RFI. - Products/Services Requested: - No direct procurement of products or services; the RFI seeks public and industry feedback. - Topics for input include: - Advancements in clinical laboratory testing technology (e.g., breath testing) - Laboratory processes and procedures - Emergency preparedness - Biosafety and biosecurity - Cybersecurity - Specialty testing areas - Unique/Notable Requirements: - The RFI is strictly for information gathering to inform future regulatory updates to CLIA. - Stakeholder feedback will help shape future policy and regulatory proposals. - No immediate purchase or contract will result from this notice.

Description

This request for information (RFI) issued by the Centers for Medicare & Medicaid Services (CMS) and the Centers for Disease Control and Prevention (CDC) seeks public input on potential updates to the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations. The RFI focuses on advancements in clinical laboratory testing technology and covers topics including breath testing, laboratory processes and procedures, emergency preparedness, biosafety, biosecurity, cybersecurity, and specialty testing areas. The input gathered will help inform future regulatory proposals or policy guidance to update the existing CLIA regulations. Comments are due by September 14, 2026.

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