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

Hozzl · 2023-01-11T13:31:21Z

Explore the details of House Bill 2443 To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics. currently in Congress. Get insights into its purpose, current status, sponsors, and potential impact on Health. Stay informed on legislative developments.

1/11/2023, 1:31 PM

Congressional Summary of HR 2443

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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Current Status of Bill HR 2443

Bill HR 2443 is currently in the status of Bill Introduced since May 19, 2015. Bill HR 2443 was introduced during Congress 114 and was introduced to the House on May 19, 2015. Bill HR 2443's most recent activity was Referred to the Subcommittee on Health. as of May 22, 2015

Bipartisan Support of Bill HR 2443

Total Number of Sponsors

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Republican Sponsors

Unaffiliated Sponsors

Total Number of Cosponsors

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Policy Area and Potential Impact of Bill HR 2443

Primary Policy Focus

Health

Potential Impact Areas

Administrative law and regulatory proceduresDepartment of Health and Human ServicesDrug safety, medical device, and laboratory regulation

Alternate Title(s) of Bill HR 2443

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