H.R. 2422: To amend the Federal Food, Drug, and Cosmetic Act with respect to third-party quality system assessment.
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H.R. 2422: To amend the Federal Food, Drug, and Cosmetic Act with respect to third-party quality system assessment.
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 third-party quality system assessment.
Plain summary
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to establish a third-party quality system assessment program to accredit persons to assess whether a medical device manufacturer's quality system can ensure the safety and effectiveness of an approved medical device after certain changes, including changes in manufacturing or changes to enhance device safety. Device manufacturers are allowed to make changes to a device without submitting to the FDA the 30-day notice required for manufacturing changes or a premarket approval supplement if their quality system has been certified by an accredited person. An accredited person who assesses a device manufacturer's quality system must submit a summary of their assessment and, as appropriate, a certification to the FDA within 30 days of the assessment. An assessment summary and certification is deemed accepted by the FDA 30 days after submission unless the FDA determines that additional information is needed to support certification, the assessment or certification is unwarranted, or an action other than acceptance of the certification is otherwise justified. Periodic reports by device manufacturers must describe any changes made to a device without submission of the 30-day notice or the premarket approval supplement. Certifications accepted by the FDA remain in effect for two years. The FDA must report on this quality system assessment program no later than January 31, 2022. The program is terminated at the end of FY2022.
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 third-party quality system assessment.
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 (2)
- Appropriation
- Money a legislature sets aside by law for a specific purpose. Government agencies may spend public money only as it has been appropriated.
- 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).
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-114hr2422.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/114/hr>
Record fed-us-cong114-hr2422 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114