H.R.2443: To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics.

About This Bill

  • This bill was introduced in the 114th Congress
  • This bill is primarily about health
  • Introduced May 19, 2015
  • Latest Major Action May 22, 2015

Bill 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.

(Source: Library of Congress)

Bill Actions

Date Description
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 the House by Brett Guthrie (R-Ky.)

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