H.R. 2337: To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices.
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H.R. 2337: To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices.
114th Congress · introduced 2015-05-14 · Health · Latest: Referred to the Subcommittee on Health.
federal
Follow this bill, step by step
- Where it came from: introduced 2015-05-14 · official record
- Who proposed it: Rep. Pitts, Joseph R. [R-PA-16] · 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 to authorize priority review for breakthrough devices.
Plain summary
This bill amends the Federal Food, Drug, and Cosmetic Act to replace the requirement that the Food and Drug Administration (FDA) prioritize review of breakthrough medical devices with a requirement that the FDA establish a program to provide priority review for breakthrough medical devices. Prior to submitting an application for approval, a medical device sponsor may request that the FDA designate the medical device for priority review. The FDA must provide a summary of the basis for its determination regarding designation. To expedite the development and review of designated medical devices, the FDA must: assign a team of staff for each device, adopt an efficient process for dispute resolution, provide for interactive communication with the device sponsor, expedite review of manufacturing and quality systems compliance, disclose to the sponsor in advance the topics of any consultation between the FDA and external experts or an advisory committee and provide the sponsor the opportunity to recommend external experts, assign staff to address questions by institutional review committees concerning investigational use of the device. The FDA may: (1) coordinate with the sponsor regarding early agreement on a data development plan; (2) take steps to ensure that the design of clinical trials is as efficient as practicable; (3) utilize timely postmarket data collection; and (4) agree to clinical protocols, subject to an FDA determination that changes are required to prevent an unreasonable risk to the public health or that a substantial scientific issue is essential to the safety or effectiveness of the device.
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 to authorize priority review for breakthrough devices.
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. Pitts, Joseph R. [R-PA-16] · 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)
- Authorization
- A law that creates or continues a government program and says what it may do, often with a suggested spending ceiling. An authorization alone does not provide money; a separate appropriation does.
- 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).
- Resolution
- A formal statement or decision by a legislative body. Simple resolutions often only express an opinion or set rules for one chamber; they do not become law.
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-114hr2337.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/114/hr>
Record fed-us-cong114-hr2337 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114