United States 114th Congress Status: Died 1 R cosponsors

S 1077 — Advancing Breakthrough Devices for Patients Act of 2016

Last action — Placed on Senate Legislative Calendar under General Orders. Calendar No. 412.

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  1. ✓
    Introduced
  2. Died in session

This bill died with 114th Congress. It reached “Introduced” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.

This bill is no longer active — its legislative session has ended, so there is no live prognosis. It would have to be reintroduced in the current session to move again.

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.

Bill Text

We don't have the full text on file for this bill yet.

Read S 1077 on the official United States source →

Action History

  1. Placed on Senate Legislative Calendar under General Orders. Calendar No. 412.

  2. Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.

  3. Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.

  4. Read twice and referred to the Committee on Health, Education, Labor, and Pensions.

Sponsors

Sponsorship breakdown

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1 sponsors · 0 co-sponsors · 546 not signed on

Sponsors (1)

Co-sponsors (0)

None.

Not signed on (546)

546 members have not signed on to this bill.

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"Not signed on" means a member has not sponsored or co-sponsored this bill — it does not imply opposition. Members flagged Voted No have a recorded No vote on this bill.

Whip count is in markup. Polling the chamber and every recorded vote this session. Only the first open is slow. It’s instant for you after this. Calling the roll · Tallying · Engrossing

Subjects

Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Health
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Frequently asked questions

What does S 1077 do?
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.
Who sponsors S 1077?
S 1077 is sponsored by Richard Burr (R).
What is the current status of S 1077?
This bill died with 114th Congress. It reached “Introduced” and never advanced before the session ended, so it can no longer move — a new version would have to be reintroduced in the current session.
Where can I track S 1077?
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