Proposed Senate Bill Would Create Expedited Approval Path for Novel Device Technology

Sens. Richard Burr (R-N.C.), Michael Bennet (D-Colo.), and Orrin Hatch (R-Utah) introduced a bipartisan bill to help fast-track novel medical device approval through the U.S. Food and Drug Administration (FDA).

The proposed legislation, titled the “Advancing Breakthrough Devices for Patients Act” builds on the Advancing Breakthrough Therapies for Patients Act, which the Senate passed in 2012 from Senators Bennet, Hatch, and Burr. Both the 2012 legislation and the newly introduced bill share similar principles, such as an “all hands-on-deck” approach to devices, while also complementing and enhancing the existing tools, such as priority review, currently in place for devices, with the goal of expediting the development and review of breakthrough products, according to the bill’s sponsors.

“America is the world’s most innovative nation, especially in our medical research and development. America’s patients deserve access to the latest, most cutting-edge life-saving therapies and devices, and we need to advance these innovative medical products, including breakthrough devices. FDA can be a key partner in this important endeavor,” said Burr. “This legislation ensures that America’s patients are receiving the most innovative technologies in as timely a manner as possible by improving regulatory certainty and applying an all-hands-on-deck approach to the development and review of these devices. I am excited to see this legislation move forward with the help of my two trusted colleagues, Senators Bennet and Hatch.”

“Americans ought to benefit from the latest life-saving research and innovative devices developed by the medical community, and this measure ensures FDA can give a helping hand. By streamlining the approval process and improving regulatory certainty, we’re giving more patients a fighting chance to improve their lives,” said Hatch.

The legislation would amend the Food, Drug, and Cosmetic Act to require FDA, at the request of a device company submitting its device for approval, to expedite the development of and provide for priority review of devices that represent breakthrough technologies, for which no approved alternatives exist, offer significant advantages over existing approved or cleared alternatives, or the availability of which is in the best interest of patients.

“By setting out a clear process by which a device sponsor may request designation for expedited development and priority review, this legislation will help to clarify the path for devices to receive priority review and reach American patients in as timely a manner as possible,” the legislation’s authors wrote in a brief summary of the bill. “If the FDA determines that a device meets the necessary ‘breakthrough’ criteria, then the agency shall take key actions to expedite the development and priority review of such designated devices, which may include taking steps to ensure that the design of clinical trials is as efficient as practicable, when scientifically appropriate, and agreement on clinical protocols.”

In order to promote regulatory certainty with respect to breakthrough devices, the bill also would require the FDA to issue final guidance on authorities relating to breakthrough devices.

“While FDA has made great strides in recent years to improve the efficiency and predictability of the medical technology review process, more can be done to ensure that the most cutting-edge innovations—those that have the potential to provide the greatest patient benefit—are made available to patients and physicians, something the agency acknowledges as well,” said Stephen Ubl, president and CEO of the Advanced Medical Technology Association.