09/24/2018: Lab Update: Information from CMS and FDA about Emergency Use Authorized Assays

Audience: Clinical Laboratory Partners, Clinical and Public Health Laboratories

Subject line: LOCS Notice: Lab Update: Information from CMS and FDA about Emergency Use Authorized Assays

Level: Lab Update

Dear LOCS members,

The Centers for Medicare and Medicaid Services recently published a memo to their surveyors explaining policy related to the Clinical Laboratory Improvement Amendments (CLIA) regulations as they apply to Emergency Use Authorized (EUA) Assays. This memo discusses laboratory compliance with CLIA regulations and the verification of performance specifications for EUA assays.

Also, the Food and Drug Administration (FDA) has websites that provide additional information about available EUA assays. One webpage lists current Emergency Use Authorizations (EUA) for diagnostic and therapeutic medical devices to diagnose and respond to public health emergencies. Each pathogen-specific EUA includes links to information for the device-specific Letter of Authorization, fact sheets, and manufacturer instructions/package inserts. These documents are updated when amendments are made (e.g., additional specimen types, extraction methods, procedural clarifications, etc.) and should be routinely checked to ensure laboratories have the most up-to-date information.

Other FDA webpages list EUA information specific for molecular-based Zika virus assays.  For example, one FDA webpage summarizes the results of testing FDA Reference Material Panels, along with some other Molecular Zika Virus Emergency Use Authorization Assays Performance Characteristics, determined during the EUA evaluation. In addition, another FDA webpage has a summary of Molecular Zika Virus Emergency Use Authorization Assays Key Characteristics.

Please share this email with your member laboratories.

Thank you,

The Laboratory Outreach Communication System (LOCS)

LOCS@cdc.gov