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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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 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
 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.

 Committees of jurisdiction 2