Gardner Introduces Bills to Streamline Medical Device Approval Process

Washington, DC – Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) today introduced the Rare Disease Innovation Act and the FDA Regulatory Efficiency Act, two bills that would streamline the U.S. Food and Drug Administration (FDA) approval process for certain medical devices.  

The Rare Disease Innovation Act paves the way for the manufacture and approval of medical devices that diagnose or treat individuals with rare diseases. This legislation will expand an existing program which simplifies and expedites the FDA approval of medical devices that will treat the rarest of diseases such as ALS, cerebral palsy, Hodgkin’s lymphoma, mesothelioma, and tuberculosis, in addition to many others. Right now, FDA has a simplified and expedited approval process for medical devices intended to treat or diagnose rare diseases that are present in 4,000 patients or fewer in the U.S. annually. The Rare Disease Innovation Act increases the threshold from 4,000 to 8,000 patient cases for medical devices that will qualify for expedited and simplified approval. Without this process, the research and development costs associated with these devices is not economical. By increasing the threshold from 4,000 to 8,000 patient cases, the Rare Disease Innovation Act creates an incentive for manufacturers to develop medical devices for rare diseases to help  people with rare conditions gain access to technologies they would not otherwise.  

The FDA Regulatory Efficiency Act provides the FDA with the authority to transfer the initial review of 510(k) medical devices to accredited third parties that apply for approval through the FDA. 510(k) devices are low-risk medical devices that are substantially similar to devices that have already been approved by the FDA. Examples of 510(k) devices include powered wheelchairs, shunts, and CT scanners. By allowing accredited third parties to conduct the initial review of these devices, this legislation allows the FDA to spend more time reviewing new breakthrough technologies and expedite them to the market for patients who need them.  

“Streamlining the medical device approval process will enhance the quality of healthcare for those living in Colorado and across America,” said Gardner. “While the Rare Disease 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 said, “As a global leader in the device and pharmaceutical industries, the United States including my home state of Indiana is at the forefront of life-saving research. 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. I am pleased to partner with my friend Senator Gardner, and I look forward to working with my colleagues on both sides of the aisle to advance this legislation.”