06.18.15

Burr, Franken Introduce Bill to Bring Medical Devices to Patients Faster

WASHINGTON – Today, U.S. Senators Richard Burr (R-NC) and Al Franken (D-MN) introduced the FDA Device Accountability Act. The Device Act would eliminate the unnecessary burdens that are slowing down the FDA’s consideration of new, innovative medical devices.  This legislation would allow Americans to benefit from new medical devices as quickly as possible.

“America is a global leader in medical research, development, and innovation,” said Senator Burr.  “Ensuring that safe medical devices are developed and reviewed quickly will help get them to patients faster, which will improve and save lives.  This legislation will also help cut down on the total time it takes for patients to benefit from approved medical devices by permitting more efficient clinical trials. As Congress works to support innovation for healthier Americans, I hope my colleagues will see the benefit of these commonsense solutions and join me in supporting them.”

“For the companies in Minnesota and across the country that are developing new and innovative medical technologies, the current government-approval process can be needlessly slow, frustrating, and costly,” said Sen. Franken. “Many Minnesota device makers have expressed to me that inconsistencies and lack of clarity in the regulatory process not only delay patients’ access to new devices, but they also stifle innovation at their companies and threaten jobs in our state. We can do better, and these commonsense measures will help shorten the time it takes to bring a device to market, while ensuring safety for patients who can benefit from these life-saving technologies.”

The FDA Device Accountability Act – “The Device Act” – will not only ensure that the FDA eliminates unnecessary burdens when reviewing devices, but it will also permit more efficient device clinical trials through the ability to use centralized Institutional Review Boards (IRBs); and require the FDA to update guidance on certain point-of-care tests performed in doctor’s offices.

Read the one pager on The Device Act here.