Sen. Franken Introduces Bipartisan Measure to Get Life-Saving Medical Devices to Patients Faster

WASHINGTON, D.C. [06/18/15]—Today, U.S. Sen. Al Franken (D-Minn.) introduced bipartisan legislation to eliminate unnecessary burdens that slow government approval of innovative and life-saving medical devices being produced in Minnesota and across the country.

The measure, the FDA Device Accountability Act, was introduced with Sen. Richard Burr (R-N.C.). It aims to streamline the process of getting new devices approved by requiring the federal Food and Drug Administration (FDA), which oversees product approval, to ensure their reviews are done in the “least burdensome” manner.

“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 bill 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.

Sen. Franken said the medical device industry is critically important to Minnesota, which has hundreds of innovative companies providing tens of thousands of good-paying jobs around the state.