S. 1077

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.