H.R. 2426: To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to certain class I and class II devices.
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H.R. 2426: To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to certain class I and class II devices.
114th Congress · introduced 2015-05-19 · Health · Latest: Referred to the Subcommittee on Health.
federal
Follow this bill, step by step
- Where it came from: introduced 2015-05-19 · official record
- Who proposed it: Rep. Shimkus, John [R-IL-15] · 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
To amend the Federal Food, Drug, and Cosmetic Act with respect to easing regulatory burden with respect to certain class I and class II devices.
Plain summary
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA), not later than 120 days after enactment of the 21st Century Cures Act (H.R. 6, a bill introduced on May 19, 2015), to identify types of class I medical devices (devices that do not need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, a report is needed for a class I device only if the device is of substantial importance in preventing impairment of human health or if it presents a potential unreasonable risk of illness or injury.) Not later than 180 days after enactment of the 21st Century Cures Act, the FDA must publish a list of types of class II medical devices (devices that need special controls to assure their safety and effectiveness) for which a report is no longer needed prior to marketing to provide reasonable assurance of safety and effectiveness. (Currently, such a list must be published each time the FDA exempts a type of class II device from the reporting requirement.) The public comment period for such an exemption is extended to 60 days.
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 easing regulatory burden with respect to certain class I and class II devices.
Source: Congressional Research Service summary (Introduced in House)
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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)
- 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.
- Public comment
- A chance for anyone to tell a government agency what they think about a proposed rule or plan before it is final. Agencies must consider the comments they receive.
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-114hr2426.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/114/hr>
Record fed-us-cong114-hr2426 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114