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H.R. 3847: SOUND Devices Act of 2012

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H.R. 3847: SOUND Devices Act of 2012

112th Congress · introduced 2012-01-31 · Health · Latest: Referred to the House Committee on Energy and Commerce.

federal

Follow this bill, step by step

  1. Where it came from: introduced 2012-01-31 · official record
  2. Who proposed it: Rep. Markey, Edward J. [D-MA-7] · what a sponsor is
  3. What happened next: no floor votes in our records yet. Why?
  4. Where it stands now: Referred to the House Committee on Energy and Commerce. 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

SOUND Devices Act of 2012

Plain summary

Safety Of Untested and New Devices Act of 2012 or the SOUND Devices Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require a medical device company seeking approval of a new device based on a determination of substantial equivalence to a predicate device to inform the Food and Drug Administration (FDA) if any predicate lineage products have harmed device recipients and to explain how the current device avoids past flaws. Prohibits finding a new device substantially equivalent to a predicate device if the predicate has been removed from the market by the Secretary of Health and Human Services (HHS) or determined to be misbranded or adulterated by judicial order. Permits the FDA to reject a claim of substantial equivalency for a device whose predicate has been corrected or removed from the market by its sponsor. Requires the Secretary to maintain an up-to-date database for purposes of determining whether devices are eligible for use as a predicate device. Requires each manufacturer's corrective action or removal of device report to contain the root cause of each defect leading to the corrective action or removal. Requires a manufacturer's report for devices in the same lineage as devices that have been subject to corrections or removals and requires such report to explain why the subsequent device does not share the flaws of its predecessor device. Requires the Secretary to conduct a review of all covered devices to identify any such devices with respect to which a predicate device, or any device in the full device lineage, has been corrected or removed from the market pursuant to a Class I or Class II recall.

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

SOUND Devices Act of 2012

Source: Congressional Research Service summary (Introduced in House)

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The strongest published arguments

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Alternatives

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

Officials and money

Sponsor: Rep. Markey, Edward J. [D-MA-7] · 4 cosponsors

Cost estimate: No cost estimate published yet.

Cosponsors on this site

Janice D. Schakowsky (D-IL), Rosa L. DeLauro (D-CT)

Sponsor's campaign money: Rep. Markey, Edward J. [D-MA-7] reported raising $6.0 million (2025–2026). Details. Shown for context only; it does not mean any donor supported this bill.

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.

Sources

Record fed-us-cong112-hr3847 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112