U.S. Sens. Richard Burr (R-NC) and Al Franken (D-MN) introduced legislation last week to eliminate the hurdles that are squelching the Food and Drug Administration’s (FDA) ability to consider new innovative medical devices and push them to market faster.
The FDA Device Accountability Act would allow American medical patients to reap the benefits from new devices sooner by eliminating the FDA’s duplicative, unnecessary review procedures that bog down the process of getting new devices to the public.
“America is a global leader in medical research, development and innovation,” Burr said. “Ensuring that safe medical devices are developed and reviewed quickly will help get them to patients faster, which will improve and save lives.”
The legislation also will allow more efficient clinical trials for new medical devices by allowing for the use of centrally located Institutional Review Boards (IRBs) that can share data.
“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,” Franken said. “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 Device Act also will require the FDA to update guidance based on the result of the new clinical trials and other tests performed in doctor’s offices.
”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,” Burr said.