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H.R. 2428: To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.

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H.R. 2428: To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.

114th Congress · introduced 2015-05-19 · Health · Latest: Referred to the Subcommittee on Health.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2015-05-19 · official record
  2. Who proposed it: Rep. Shimkus, John [R-IL-15] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. Where it stands now: Referred to the Subcommittee on Health. Not final yet: this can still change. We check for updates every day.
  5. If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.

What does this mean?

Official title

To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.

Plain summary

This bill amends the Federal Food, Drug, and Cosmetic Act to expand the humanitarian device exemption to authorize the Food and Drug Administration (FDA) to exempt from effectiveness requirements certain medical devices intended to benefit fewer than 8,000 individuals. Currently, the FDA may exempt devices intended to benefit fewer than 4,000 individuals. Within 18 months of enactment of this Act, the FDA must define “probable benefit” for these devices.

Congressional Research Service summary (Introduced in House), quoted unchanged (nonpartisan). Read the source.

What a vote does

A “Yea” vote

If it passes both chambers and is signed, it becomes law.

A “Nay” vote

If it is not passed, current law stays as it is.

PSI Sci description of the legislative step (not an opinion).

What does this mean? (plain words)

Official text

To amend the Federal Food, Drug, and Cosmetic Act with respect to humanitarian device exemption applications.

Source: Congressional Research Service summary (Introduced in House)

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The strongest published arguments

Arguments for (supporters)

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Arguments against (opponents)

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Alternatives

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How did my representative vote? · This bill's floor votes

Officials and money

Sponsor: Rep. Shimkus, John [R-IL-15] · 0 cosponsors

Cost estimate: No cost estimate published yet.

No linked floor roll calls in our collected records yet. This does not mean the bill has never had a vote. Check the official bill history.

Words on this page, explained (3)
Authorization
A law that creates or continues a government program and says what it may do, often with a suggested spending ceiling. An authorization alone does not provide money; a separate appropriation does.
Bill
A proposed law. It becomes law only if it passes the legislature and is signed by the president or governor (or a veto is overridden).
Exemption
A rule that removes certain people, property or activities from a tax or requirement.

Plain meanings written from linked sources. All words.

Sources

Record fed-us-cong114-hr2428 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114