The FDA lacks a good mechanism for dealing with the hundreds of device accessories currently on the market which may be inappropriately classified, and a new House bill proposes to streamline the process.
The bipartisan Risk Based Classification of Accessories Act would require the FDA to revise regulations for the reclassification of previously approved, low-risk medical devices.
Currently, an accessory like a plastic tray packaged with a medical device is required to comply with the same onerous regulations as medical technology like artificial heart valves, said Rep. Annie Kuster (D-N.H.), who introduced the bill with Rep. Mimi Walters (R.-Calif.).
The 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 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,” she said. 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, Kuster said.