FDA Reauthorization Act Passes House with Key Bipartisan Reforms for Medical Device Manufacturers Authored by Rep. Mimi Walters
WASHINGTON, DC – Today, the U.S. House of Representatives passed H.R. 2430, the Food and Drug Administration (FDA) Reauthorization Act of 2017, which would authorize user fee programs within the FDA that are critical for the health and wellbeing of patients. This bi-partisan bill will promote safety and innovation by streamlining the approval and delivery of life-saving devices and medications.
Included in this bill is language authored by Rep. Mimi Walters (R-CA) that would reform FDA regulations for the reclassification of previously approved, low-risk medical devices. This commonsense reform would ensure that such devices are not be subject to an unnecessarily high-risk classification than is appropriate for their effective use. The provision would reduce the cost of bringing these devices to the public.
Rep. Walters said, “I applaud my colleagues in the House for passing this bipartisan legislation that will provide the FDA with the resources necessary to approve and deliver lifesaving cures and treatments to market. I am encouraged that this bill also takes major strides to streamline parts of the FDA’s medical device approval process, while maintaining the safety and efficacy of those products.
“The commonsense legislation would allow previously approved, low-risk accessory devices to be classified based on the device’s own risk, not the risk classification of the device the accessory is meant to complement. This will allow for the more efficient delivery of life-saving devices to patients.
“This legislation promotes innovation, while reducing the regulatory burdens and inefficiencies that stand in the way of improving the health and lives of all Americans.”
Walters represents California’s 45th District and serves on the House Energy and Commerce Committee.