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To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.
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.
Read the Full Bill
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
1Democrat Sponsors
0Republican Sponsors
1Unaffiliated Sponsors
0Total Number of Cosponsors
0Democrat Cosponsors
0Republican Cosponsors
0Unaffiliated Cosponsors
0Policy Area and Potential Impact of Bill HR 2443
Primary Policy Focus
HealthPotential Impact Areas
- Administrative law and regulatory procedures
- Department of Health and Human Services
- Drug 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.
Comments
Sponsors and Cosponsors of HR 2443
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