Senators introduce bipartisan bills to expedite FDA approval for medical devices
Republican senator Cory Gardner (Colorado) and Democrat senator Joe Donnelly (Indiana) introduced two bills on Oct. 21 to accelerate the FDA approval process for medical devices.
The Rare Device Innovation Act would expand an existing program to simplify and expedite the review of devices intended to treat ALS, cerebral palsy, Hodgkin’s lymphoma, mesothelioma, tuberculosis and other rare disease. Currently, the FDA has an expedited approval process for diseases that affect 4,000 or fewer patients in the U.S. annually. The Rare Device Innovation Act would increase the threshold to rare diseases affecting 8,000 or fewer U.S. patients annually.
The FDA Regulatory Efficiency Act would allow accredited third parties to initially review 510(k) medical devices, which are similar to devices that are already FDA-approved. Gardner and Donnelly said in a statement that this would allow the FDA to spend more time reviewing breakthrough technologies and get them to market faster.
“Streamlining the medical device approval process will enhance the quality of healthcare for those living in Colorado and across America,” Gardner said in a statement. “While the Rare Device Innovation Act incentivizes the development of life-saving medical devices for those with rare diseases, the FDA Regulatory Efficiency Act allows the FDA to prioritize innovative medical devices that have the potential to revolutionize the health care industry. It's commonsense policy, and I look forward working with Senator Donnelly and my colleagues to support patient-centered solutions that improve quality of care while bringing down costs.”
Donnelly also announced support for three bipartisan bills: the Combination Product Regulatory Fairness Act of 2015 would improve the review of combination drugs; the Advancing Breakthrough Devices for Patients Act of 2015 would streamline the process for breakthrough innovations; and the Patient Focused Impact Assessment Act would establish a patient engagement assessment tool to incorporate patients in the drug review process.
“As a global leader in the device and pharmaceutical industries, Indiana is at the forefront of life-saving research,” Donnelly said in a news release. “We must continue to close the gap between the development of new drugs and devices and bringing safe and effective products to the public. Our policies should ensure safety and encourage innovation in order to make life-saving technologies and medicines available to the people who need them the most.”
Executive Editor
Tim Casey joined TriMed Media Group in 2015 as Executive Editor. For the previous four years, he worked as an editor and writer for HMP Communications, primarily focused on covering managed care issues and reporting from medical and health care conferences. He was also a staff reporter at the Sacramento Bee for more than four years covering professional, college and high school sports. He earned his undergraduate degree in psychology from the University of Notre Dame and his MBA degree from Georgetown University.