summary
Introduced
04/23/2015
04/23/2015
In Committee
03/09/2016
03/09/2016
Crossed Over
Passed
Dead
01/03/2017
01/03/2017
Introduced Session
114th Congress
Bill Summary
Advancing Breakthrough Devices for Patients Act of 2016 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.
AI Summary
This bill, the Advancing Breakthrough Devices for Patients Act of 2016, aims to speed up the availability of innovative medical devices by expanding the Food and Drug Administration's (FDA) priority review program to all classes of devices, not just the highest-risk Class III devices. A "sponsor" (the company or individual developing the device) can request that their device be designated as a "breakthrough device" if it offers significant advantages for treating or diagnosing serious conditions, has no approved alternatives, or is otherwise in the best interest of patients. If the FDA agrees, they will assign a dedicated team to the device, establish efficient processes for resolving disagreements, maintain open communication with the sponsor, expedite reviews of manufacturing processes, and allow the sponsor to suggest outside experts for consultations. The FDA may also work with the sponsor to create efficient clinical trial plans, use post-market data, and agree to binding clinical protocols, with limited exceptions.
Committee Categories
Health and Social Services
Sponsors (4)
Last Action
Placed on Senate Legislative Calendar under General Orders. Calendar No. 412. (on 04/05/2016)
Official Document
bill text
bill summary
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bill summary
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bill summary
| Document Type | Source Location | Created |
|---|---|---|
| State Bill Page | https://www.congress.gov/bill/114th-congress/senate-bill/1077/all-info | 04/28/2015 |
| BillText | https://www.congress.gov/114/bills/s1077/BILLS-114s1077is.pdf | 07/07/2016 |
| BillText | https://www.congress.gov/114/bills/s1077/BILLS-114s1077rs.pdf | 07/07/2016 |
| Bill | https://www.congress.gov/114/bills/s1077/BILLS-114s1077rs.pdf.pdf | 07/07/2016 |
| Bill | https://www.congress.gov/114/bills/s1077/BILLS-114s1077is.pdf.pdf | 07/07/2016 |
| BillText | http://gpo.gov/fdsys/pkg/BILLS-114s1077rs/pdf/BILLS-114s1077rs.pdf | 04/07/2016 |
| Bill | http://gpo.gov/fdsys/pkg/BILLS-114s1077rs/pdf/BILLS-114s1077rs.pdf.pdf | 04/07/2016 |
| BillText | http://gpo.gov/fdsys/pkg/BILLS-114s1077is/pdf/BILLS-114s1077is.pdf | 05/08/2015 |
| Bill | http://gpo.gov/fdsys/pkg/BILLS-114s1077is/pdf/BILLS-114s1077is.pdf.pdf | 05/08/2015 |
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