Bill114th CongressFiled May 19, 2015Health
H.R. 2443
To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.
Bill journey · stage 2 of 5
Under committee review
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What it doesSummary 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.
What just happenedMay 22, 2015
Referred to the Subcommittee on Health.
Who’s behind it
Rep. Guthrie, Brett [R-KY-2](R-KY)Sponsor
1committees4actions2related bills3subjects
- Introduced in HouseMay 19, 2015
- May 22, 2015Committee
Referred to the Subcommittee on Health.
Health Subcommittee - May 19, 2015IntroReferralH11100
Referred to the House Committee on Energy and Commerce.
Energy and Commerce Committee - May 19, 2015IntroReferralIntro-H
Introduced in House
- May 19, 2015IntroReferral1000
Introduced in House