This bill requires the Department of Health and Human Services to publish guidance that revises “Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices” and includes guidance on using comparable performance between types of users to demonstrate the accuracy of a medical device.
Received in the Senate and Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Became Public Law No: 114-255.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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