United States · Bill · HR
H.R. 2443 (114th)
To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.
Introduced
19 May 2015
Last action
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Status
Referred to the Subcommittee on Health.
Sponsors
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Subjects
Discovery layer
Source updated
7 April 2025
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.
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Documents
3 official files
Introduced in House (text)
Introduced in House (text)
Introduced in House · EN · 19 May 2015
Introduced in House (PDF)
Introduced in House · EN · 19 May 2015
Introduced in House
summary · EN · 19 May 2015
Sponsors
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Sources
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- Official source: https://www.congress.gov/bill/114th-congress/house-bill/2443
- Open data entity: https://api.congress.gov/v3/bill/114/hr/2443