April 26, 2017
Press Release

For Immediate Release

April 26, 2017

Contact: T.W. Arrighi

(202) 591-5949

 

 

Reps. Walters and Kuster Introduce Bipartisan Legislation to Streamline Medical Device Regulations

Washington, DCCongresswoman Mimi Walters (California-45) and Congresswoman Ann McLane Kuster (New Hampshire-02) released the following statements regarding their recently introduced legislation, H.R. 2144, the Risk-Based Classification of Accessories Act of 2017.  This bill would reform Food and Drug Administration (FDA) regulations for the reclassification of previously approved, low-risk medical devices. This commonsense reform would ensure that such devices are not subject to an unnecessarily high-risk classification than is appropriate for their effective use.

Walters said, “Some of the largest drivers of health care costs are the antiquated, one-size-fits all regulations that make medical devices and new technologies more expensive to bring to market.  This bipartisan legislation streamlines some of the excessive red tape that unnecessarily delays the health benefits patients receive from medical devices. This commonsense bill also eases redundant government burdens on some of Orange County’s great medical device innovators.”

Kuster said, “We need to be doing all we can to lower the cost of medical supplies and contain the high costs of healthcare. It is commonsense that an accessory that does not impact the safety of a device should not need to go through the cumbersome process for FDA approval required for a more sophisticated medical device. This bill would clarify that something like a plastic tray doesn’t need to be tested to the same degree as a high powered eye surgery laser.”

Walters represents California’s 45th District and serves on the House Energy and Commerce Committee.