United States 114th Congress Status: Died 1 R cosponsors

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

Last action — Referred to the Subcommittee on Health.

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  1. ✓
    Introduced
  2. ✓
    In Committee
  3. Died in session

This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

Summary

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

Bill Text

We don't have the full text on file for this bill yet.

Read HR 2443 on the official United States source →

Action History

  1. Referred to the Subcommittee on Health.

  2. Referred to the House Committee on Energy and Commerce.

  3. Introduced in House

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

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Subjects

healthcare technology
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Frequently asked questions

What does HR 2443 do?
To amend the Federal Food, Drug, and Cosmetic Act with respect to CLIA waiver study design guidance for in vitro diagnostics. 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.
Who sponsors HR 2443?
HR 2443 is sponsored by Brett Guthrie (R).
What is the current status of HR 2443?
This bill died with 114th Congress. It reached “In Committee” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track HR 2443?
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Last checked for changes about 12 hours ago · updated continuously

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