Legislation Would Also Address Safety of Devices Already on the Marke
WASHINGTON, DC – U.S. Senators Bob Casey (D-PA) and John McCain (R-AZ) today introduced legislation to remove burdensome regulations that hurt medical device manufacturers. Casey and McCain’s bill would streamline the pathway for medical device manufacturers to innovate and bring the most advanced technologies to the market.
“Pennsylvania companies eager to expand their business and bring new products to the market should not have to endure unnecessary and outdated bureaucratic processes,” said Senator Casey. “This bill would make it easier for manufacturers to bring their new medical devices to the market as well as increase medical device safety, which will protect consumers and help Pennsylvania manufacturers grow and innovate. I am pleased to work in a bipartisan way with Senator McCain on this bill to create jobs and help our nation’s manufactures innovate.”
“The FDA’s current approval process for medical devices can be cumbersome, inconsistent and far too lengthy for patients who need innovative technologies and for the companies that develop them,” said Senator John McCain. “With the U.S. medical device industry struggling to maintain international leadership, this legislation streamlines the outdated regulatory approval process to improve patients’ access to safe and effective medical devices. I am pleased to join Senator Casey to introduce this legislation that will help patients while fostering innovation and growing jobs in our medical device industry.”
Currently, medical device manufacturers must put new products through a review process with the FDA to determine that there is not a similar device already on the market, even if it is already known that a similar device does not exist. This process can take years and slows the development of new technologies, hindering companies in Pennsylvania, Arizona and across the country.
The Casey-McCain bill, the Safe, Efficient and Transparent Medical Device Approval Act, or SET Device Act, would streamline the FDA review process by allowing medical device manufacturers to submit new products for direct approval without the burdensome review to determine if there are similar products already on the market.
The bill would also address safety issues by ensuring that medical devices on the market before current safety classification systems existed are properly classified in a timely manner.