H.R. 2443 · 114th Congress
To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in…
Full title
To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.
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Never voted on. It didn't reach a floor vote before the 114th Congress ended, so it expired. A bill has to be introduced again to be considered in a new Congress.
R
GuthrieSponsorNo cosponsors.
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…
What it does: CRS summary · Introduced in House · May 19, 2015
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.
Written by the nonpartisan Congressional Research Service. All summary versions on Congress.gov
About this bill and sources
Official title: To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.
Latest action (May 22, 2015): Referred to the Subcommittee on Health.
Policy area: Health · Origin: House · Introduced: May 19, 2015
Official page on Congress.gov · Bill text (GovInfo) · Status record (XML)
No recorded floor vote found.