Today Congresswomen Annie Kuster (NH-02) and Mimi Walters (CA-45) announced the introduction of the Risk-Based Classification of Accessories Act. This bipartisan legislation would clarify the process by which an accessory, which could be a component like a plastic tray packaged with a medical device, is classified by the Food and Drug Administration (FDA). Currently, an accessory is required to comply with the same onerous regulations, such as unnecessary testing, as medical technology like artificial heart valves. Often, accessories are approved by the FDA as independent devices and only require additional and inappropriate scrutiny after they are paired with more risky medical devices. This approval process increases costs for manufacturers that are often passed on to consumers. The Risk-Based Classification of Accessories Act would ensure an accessory does not need to unnecessarily go through the approval process required for a sophisticated medical device.

“We need to be doing all we can to lower the cost of medical supplies and contain the high costs of healthcare,” said Congresswoman Kuster. “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.”

“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,” said Congresswoman Walters. “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.”

"Smiths Medical applauds Congresswoman Kuster's leadership for introducing the ‘Risk-Based Classification of Accessories Act of 2017’, to streamline the classification of medical device accessories, as directed by the 21 Century Cures Act,” said Chris Swonger, SVP, Global Government Relations. “Smiths Medical and our over 350 employees in Keene, New Hampshire value the Congresswoman's backing of life sciences in support of patients."

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