S. 1077: Advancing Breakthrough Devices for Patients Act of 2016

114th Congress · introduced 2015-04-23 · Health · Latest: Placed on Senate Legislative Calendar under General Orders. Calendar No. 412.

federal

Follow this bill, step by step

Where it came from: introduced 2015-04-23 · official record
Who proposed it: Sen. Burr, Richard [R-NC] · what a sponsor is
What happened next: no floor votes in our records yet. Why?
Where it stands now: Placed on Senate Legislative Calendar under General Orders. Calendar No. 412. 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.

What does this mean?

Official title

Advancing Breakthrough Devices for Patients Act of 2016

Plain summary

Advancing Breakthrough Devices for Patients Act of 2016 (Sec. 2) This bill amends the Federal Food, Drug, and Cosmetic Act to revise requirements regarding priority review of breakthrough medical devices. Upon a sponsor's request, the Food and Drug Administration (FDA) must determine whether a device meets the criteria for designation as a breakthrough device. 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 and timely 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 and flexible as practicable; (3) utilize timely postmarket data collection; and (4) agree to clinical protocols, subject to a decision that a substantial scientific issue essential to determining the safety or effectiveness of the device exists. The FDA must issue guidance and report on this priority review process.

Congressional Research Service summary (Reported to Senate with amendment(s)), 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

Advancing Breakthrough Devices for Patients Act of 2016

Source: Congressional Research Service summary (Reported to Senate with amendment(s))

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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. Burr, Richard [R-NC] · 3 cosponsors

Cost estimate: CBO cost estimate: S. 1077, Advancing Breakthrough Devices for Patients Act of 2016 (2016-06-28)

Cosponsors on this site

Michael F. Bennet (D-CO)

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)

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 (Reported to Senate with amendment(s))
Congress.gov
Data: GovInfo BILLSTATUS bulk data (Library of Congress), BILLSTATUS-114s1077.xml <https://www.govinfo.gov/bulkdata/BILLSTATUS/114/s>

Record fed-us-cong114-s1077 · catalog fed-us-congress-bills-cong114 · updated 2026-11-15 by psicol fed-bills-cong114