H.R. 5341: Sentinel Assurance for Effective Devices Act of 2012
Before you vote › Federal bills
H.R. 5341: Sentinel Assurance for Effective Devices Act of 2012
112th Congress · introduced 2012-05-07 · Health · Latest: Referred to the Subcommittee on Health.
federal
Follow this bill, step by step
- Where it came from: introduced 2012-05-07 · official record
- Who proposed it: Rep. Capps, Lois [D-CA-23] · what a sponsor is
- What happened next: no floor votes in our records yet. Why?
- Where it stands now: Referred to the Subcommittee on Health. 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
Sentinel Assurance for Effective Devices Act of 2012
Plain summary
Sentinel Assurance for Effective Devices Act of 2012 - Amends the Federal Food, Drug, and Cosmetic Act to require the Secretary of Health and Human Services (HHS) to: (1) amend the new drug approval application procedures to make the postmarket risk identification and analysis system applicable, with certain exceptions, to devices; (2) give priority to class II and class III devices; and (3) engage outside stakeholders in development of the system and gather information from them regarding the content of an effective sentinel program through measures involving the public. Exempts the collection of voluntary information from health care providers for purposes of postmarket risk identification for devices from application of provisions for the coordination of federal information policy. Requires the Secretary to issue final regulations concerning a unique device identification system no later than December 31, 2012, and to implement such system for class III devices no later than one year after the date of issuance of final regulations; for implantable, life-sustaining, and life-supporting devices no later than three years after such date; and for all other devices no later than five years after such date.
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
Sentinel Assurance for Effective Devices Act of 2012
Source: Congressional Research Service summary (Introduced in House)
AI explanation – may be wrong, check the official text
No AI explanation yet. It takes up to a minute to write and is then saved for everyone.
Limited to a few requests an hour per person.
The strongest published arguments
Arguments for (supporters)
Needs sources: no published arguments on this side yet. We only show items backed by a published source. Suggest one.
Arguments against (opponents)
Needs sources: no published arguments on this side yet. We only show items backed by a published source. Suggest one.
Alternatives
Needs sources: no published alternatives yet (for example a different bill, a law instead of an amendment, or keeping current law). We only show items backed by a published source. Suggest one.
How did my representative vote? · This bill's floor votes
Officials and money
Sponsor: Rep. Capps, Lois [D-CA-23] · 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 (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 House)
- Congress.gov
- Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-112hr5341.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/112/hr>
Record fed-us-cong112-hr5341 · catalog fed-us-congress-bills-cong112 · updated 2026-11-15 by psicol fed-bills-cong112