Two congresswomen on Tuesday introduced a bill in the U.S. House of Representatives that aims to streamline the FDA's review process for medical device accessories.
The Risk-Based Classification of Accessories Act seeks to revamp device accessory approvals at the FDA so lower risk accessories—such as a plastic tray packaged with a device—won't undergo the same scrutiny as higher-risk products. The FDA does not have the ability to create an appropriate risk-based classification system for current device accessories without congressional approval.
The bill could save manufacturers money by eliminating unnecessary review processes and ultimately reduce the cost of healthcare, Reps. Mimi Walters (R-Calif.) and Ann Kuster (D-N.H.), the bill's sponsors, said.
The 21st Century Cures Act included a provision directing the FDA to classify device accessories that are independent to their parent devices separately, correcting a flaw in the agency's review process that led to unnecessary higher-risk classifications, according to Scott Whitaker, president and CEO of the Advanced Medical Technology Association, which represents devicemakers. Yet, it did not authorize the FDA to reclassify accessories currently on the market, he said.
"A tailored review approach for device accessories would improve FDA's efficiency and save the agency resources while ensuring patients continue to benefit from safe and effective medical technologies," Whitaker said in a statement.
The proposed legislation would allow the developer of a new device to recommend a classification to the FDA based on relevant data. It would also authorize the FDA to efficiently re-classify accessories currently on the market.
The bill would reduce costs for manufacturers that are often passed on to consumers, legislators said.
"We need to be doing all we can to lower the cost of medical supplies and contain the high costs of healthcare," Kuster said in a statement.
