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

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.

Congress
114
Number
HR - 2443
Introduced on
2015-05-19
# Amendments
0
Sponsors
+5

Variations and Revisions

5/19/2015
Text
PDF
XML

Status of Legislation

Bill Introduced
Introduced to House
House to Vote
Introduced to Senate
Senate to Vote

Purpose and Summary

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.

Alternative Names
Official Title as IntroducedTo amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.
Policy Areas
Health
Potential Impact
Administrative law and regulatory procedures•
Department of Health and Human Services•
Drug safety, medical device, and laboratory regulation

Comments

Recent Activity

Latest Summary6/9/2015

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 Devi...

Latest Action5/22/2015
Referred to the Subcommittee on Health.