H.R. 2443
Referred to CommitteeTo amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.
Latest Action
Referred to the Subcommittee on Health.
5/22/2015 • House
Summary
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.
Introduced in House • 5/19/2015
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Bill Journey
Originated in the House
Introduced
May 19, 2015
Referred to the House Committee on Energy and Commerce.
Committee Review
Floor Debate
Passed Chamber
Other Chamber
President
Enacted into Law