PlainBillCongress, translated.Legislation. Context. Public interest.Placed on Senate Legislative Calendar under General Orders. Calendar No. 412.
Congressional Research Service
Version 01 · Reported to Senate with amendment(s) · Apr 5, 2016
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:
Showing the opening paragraphs of the official summary.
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.
People & committees
Sen. Burr, Richard [R-NC] · R–NC
Legislative record
A procedural vote is different from passage. Passage in one chamber does not establish enactment. Explore the glossary.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 412.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Introduced in Senate
Primary sources
Text links open the official source. We currently store references to these documents.
Source last updated: Apr 21, 2025. Consult Congress.gov for the current record.
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