United States 114th Congress Status: Died 1 R cosponsors

HR 2424 — To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept.

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This bill is no longer active — its legislative session has ended, so there is no live prognosis.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 training and oversight in least burdensome appropriate means concept. This bill amends the Federal Food, Drug, and Cosmetic Act to require Food and Drug Administration (FDA) employees involved in reviewing premarket submissions of medical devices to receive training regarding the "least burdensome appropriate means" concept. (Currently, the FDA must consider evaluating medical devices by the least burdensome appropriate means that would have a reasonable likelihood of resulting in approval.) The ombudsman for the FDA unit responsible for the premarket review of devices must audit this training and include in the audit interviews with persons from industry regarding their experience in the device premarket review process. When the FDA requests additional information about a medical device that is required to have premarket approval, it must consider the least burdensome appropriate means necessary for an applicant to demonstrate the safety and effectiveness of the device.

Bill Text

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

Read HR 2424 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 2424 do?
To amend the Federal Food, Drug, and Cosmetic Act with respect to training and oversight in least burdensome appropriate means concept. This bill amends the Federal Food, Drug, and Cosmetic Act to require Food and Drug Administration (FDA) employees involved in reviewing premarket submissions of medical devices to receive training regarding the "least burdensome appropriate means" concept. (Currently, the FDA must consider evaluating medical devices by the least burdensome appropriate means that would have a reasonable likelihood of resulting in approval.) The ombudsman for the FDA unit responsible for the premarket review of devices must audit this training and include in the audit interviews with persons from industry regarding their experience in the device premarket review process. When the FDA requests additional information about a medical device that is required to have premarket approval, it must consider the least burdensome appropriate means necessary for an applicant to demonstrate the safety and effectiveness of the device.
Who sponsors HR 2424?
HR 2424 is sponsored by John Shimkus (R).
What is the current status of HR 2424?
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 2424?
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Last checked for changes about 16 hours ago · updated continuously

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