Mimi Walters
Bipartisan legislation introduced by U.S. Rep. Mimi Walters (R-CA) on Wednesday would reform Food and Drug Administration regulations to ensure low-risk medical devices aren’t subjected to unnecessary high-risk classifications.
The Risk-Based Classification of Accessories Act, H.R. 2144, would reform FDA regulations to ensure that medical devices are subjected to regulations that accurately reflect their uses.
“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,” Walters, a member of the House Energy and Commerce Committee, said. “This bipartisan legislation streamlines some of the excessive red tape that unnecessarily delays the health benefits patients receive from medical devices.”
She said the bill would also ease redundant government burdens on some of Orange County’s medical device companies.
U.S. Rep. Ann McLane Kuster (D-NH), who introduced the bipartisan bill with Walters, said Congress should do all that it can to lower the cost of medical supplies and contain the high costs of health care.
“It is common sense 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. “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.”