3.0.0 1077 2023-01-11T13:27:26Z 2023-01-11T13:27:26Z Senate S 2015-04-23 114 sshr00 Health, Education, Labor, and Pensions Committee Senate Standing Reported by 2016-04-05T20:24:45Z Markup by 2016-03-09T15:00:00Z Referred to 2015-04-23T19:50:37Z To amend the Federal Food, Drug, and Cosmetic Act to authorize priority review for breakthrough devices. 114 2337 HR 2015-05-15 Referred to the Subcommittee on Health. Related bill CRS 21st Century Cures Act 114 34 HR 2016-12-13 Became Public Law No: 114-255. Related bill CRS 2016-04-05 Senate Placed on Senate Legislative Calendar under General Orders. Calendar No. 412. Calendars 2016-04-05 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 2016-04-05 Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report. Committee 14000 9 Library of Congress sshr00 Health, Education, Labor, and Pensions Committee 2016-03-09 sshr00 Health, Education, Labor, and Pensions Committee Senate Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably. Committee 2015-04-23 sshr00 Health, Education, Labor, and Pensions Committee Senate Read twice and referred to the Committee on Health, Education, Labor, and Pensions. IntroReferral 2015-04-23 Introduced in Senate IntroReferral 10000 9 Library of Congress B001135 Sen. Burr, Richard [R-NC] Richard Burr R NC Mauze N B001267 Sen. Bennet, Michael F. [D-CO] Michael Bennet D CO 2015-04-23 True H000338 Sen. Hatch, Orrin G. [R-UT] ORRIN HATCH R UT GRANT 2015-04-23 True D000607 Sen. Donnelly, Joe [D-IN] Joe Donnelly D IN 2015-10-20 False 2016-06-28T11:58:00Z S. 1077, Advancing Breakthrough Devices for Patients Act of 2016 https://www.cbo.gov/publication/51719 As reported by the Senate Committee on Health, Education, Labor, and Pensions on April 5, 2016 Health Drug safety, medical device, and laboratory regulation Health technology, devices, supplies Health 00 2015-04-23 Introduced in Senate 2016-03-09T20:01:02Z Advancing Breakthrough Devices for Patients Act of 2015

This bill amends the Federal Food, Drug, and Cosmetic Act to expand the Food and Drug Administration's (FDA's) priority review of breakthrough medical devices to include all classes of devices. Currently, only class III (new or highest risk) devices are eligible.

Upon a sponsor's request, the FDA must determine whether a device meets the criteria for priority review 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 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.]]> 01 2016-04-05 Reported to Senate with amendment(s) 2016-12-09T22:28:45Z 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.

]]> Advancing Breakthrough Devices for Patients Act of 2016 Display Title Advancing Breakthrough Devices for Patients Act of 2016 Official Title as Introduced A bill to provide for expedited development of and priority review for breakthrough devices. Introduced in Senate IS Short Titles as Introduced Advancing Breakthrough Devices for Patients Act of 2015 Short Titles as Reported to Senate Advancing Breakthrough Devices for Patients Act of 2016 S Senate Reported to Senate 2016-04-05T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s1077rs/xml/BILLS-114s1077rs.xml Introduced in Senate 2015-04-23T04:00:00Z https://www.govinfo.gov/content/pkg/BILLS-114s1077is/xml/BILLS-114s1077is.xml 2016-04-05 Placed on Senate Legislative Calendar under General Orders. Calendar No. 412. text/xml EN Pursuant to Title 17 Section 105 of the United States Code, this file is not subject to copyright protection and is in the public domain. Congressional Research Service, Library of Congress This file contains bill summaries and statuses for federal legislation. A bill summary describes the most significant provisions of a piece of legislation and details the effects the legislative text may have on current law and federal programs. Bill summaries are authored by the Congressional Research Service (CRS) of the Library of Congress. As stated in Public Law 91-510 (2 USC 166 (d)(6)), one of the duties of CRS is "to prepare summaries and digests of bills and resolutions of a public general nature introduced in the Senate or House of Representatives". For more information, refer to the User Guide that accompanies this file.