S. 2067: SET Device Act
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S. 2067: SET Device Act
112th Congress · introduced 2012-02-02 · Health · Latest: Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
federal
Follow this bill, step by step
- Where it came from: introduced 2012-02-02 · official record
- Who proposed it: Sen. Casey, Robert P., Jr. [D-PA] · what a sponsor is
- What happened next: no floor votes in our records yet. Why?
- Where it stands now: Read twice and referred to the Committee on Health, Education, Labor, and Pensions. Not final yet: this can still change. We check for updates every day.
- If it becomes law and spends money: follow the money to money laws, then agencies and contracts and grants.
Official title
SET Device Act
Plain summary
Safe, Efficient, and Transparent Medical Device Approval Act or the SET Device Act - Directs the Secretary of Health and Human Services (HHS), within 120 days of enactment of this Act, to establish the schedule for the promulgation of a regulation requiring premarket approval for a medical device that the Secretary requires to remain in class III. Directs the Secretary, within 18 months, to: (1) issue a final regulation for each device that the Secretary requires to remain in class III, and (2) establish the required special controls for each device that is classified into class II pursuant to a determination revising such devise's classification. Amends the Federal Food, Drug, and Cosmetic Act to permit a person to: (1) submit a request for initial classification of a device that has not previously been classified under such Act if the person declares that there is no legally marketed device upon which to base a substantial equivalence determination; and (2) recommend to the Secretary a classification for the device and include in the request an initial draft proposal for applicable special and general controls that are necessary to provide reasonable assurance of safety and effectiveness. Permits the Secretary to decline to undertake a classification request if the Secretary identifies a legally marketed device that could provide a reasonable basis for review of substantial equivalence or if the Secretary determines that the device submitted is not of low-moderate risk.
Congressional Research Service summary (Introduced in Senate), 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)
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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: Sen. Casey, Robert P., Jr. [D-PA] · 1 cosponsors
Cost estimate: No cost estimate published yet.
Cosponsors on this site
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 (1)
- Rulemaking
- The process agencies use to write regulations that carry out laws passed by Congress or a legislature. Usually an agency publishes a proposed rule, takes public comments, then publishes a final rule.
Plain meanings written from linked sources. All words.
Sources
- Congressional Research Service summary (Introduced in Senate)
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-112s2067.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/112/s>
Record fed-us-cong112-s2067 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112