Kuster-Backed Legislation to Clarify Classification of Accessories Adopted by FDA
(Washington, DC) – Today, Congresswoman Annie Kuster (NH-02) welcomed the adoption of the Risk-Based Classification of Accessories Act as part of the FDA Reauthorization Act of 2017. This bipartisan legislation, which was introduced by Kuster and Congresswoman Mimi Walters (CA-45) in April, would clarify the process by which an accessory is classified by the FDA and would ensure that accessories do not need to unnecessarily go through the approval process required for more advanced medical devices. This approval process increases costs for manufacturers that are often passed on to consumers.
“I’m pleased by the adoption of this important piece of legislation,” said Congresswoman Kuster. “When an accessory poses no threat to a medical device’s safety, that accessory shouldn’t have to go through the same burdensome approval process that the FDA uses for those more sophisticated devices. This bill is a step toward lowering the cost of medical supplies and containing the high costs of healthcare.”