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HR 2443 114th Congress House Health Administrative law and regulatory procedures Department of Health and Human Services Drug safety, medical device, and laboratory regulation

To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.

Introduced: May 19, 2015 Introduced by: Guthrie, Brett Republican · Kentucky See on congress.gov
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This bill died when the 114th Congress ended
It never became law before the 114th Congress (2015–2016) adjourned, and bills don't carry over to the next Congress. It would have to be reintroduced. You can still save it for reference, but it won't receive updates.
 Everywhere this bill has been 3 steps
Introduced
In committee
Reported out
Passed House
Passed Senate
To President
Became law
May 22, 2015
Referred to the Subcommittee on Health.
May 19, 2015
Referred to the House Committee on Energy and Commerce.
May 19, 2015
Introduced in House
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 Plain-English summary Congressional Research Service

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's happening now May 22, 2015

Referred to the Subcommittee on Health.

 Related & companion bills 2
  • HR 6 Related bill 21st Century Cures Act
  • HR 34 Related bill 21st Century Cures Act
 Bill text 1 version

Source documents hosted by congress.gov.

 Committees of jurisdiction 2
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APA
U.S. Congress. (2026). H.R. 2443: To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.. 114th Congress. Open America. https://openamerica.io/bill/114-HR-2443/
MLA
"H.R. 2443: To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.." 114th Congress, 2026, Open America, https://openamerica.io/bill/114-HR-2443/.
Bluebook (legal)
H.R. 2443, 114th Cong. (2026), https://openamerica.io/bill/114-HR-2443/.
Markdown link
[H.R. 2443: To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.](https://openamerica.io/bill/114-HR-2443/)
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