FDA Plans Pilot In Bid To Spur Ethylene Oxide Sterilization Alternatives

By Kelly Lienhard / November 25, 2019 at 6:29 PM
FDA on Monday (Nov. 25) announced a series of steps to spur development of new ways to sterilize medical devices that don’t rely on ethylene oxide, including a voluntary pilot program under which companies that use ethylene oxide would submit a master file when changing locations or sterilization processes. The closure of multiple ethylene oxide producing sites due to high levels of ethylene oxide emissions has led the agency to look into alternatives to prevent a future shortage of essential...

Not a subscriber? Sign up for 30 days free access to exclusive, detailed reporting on drug pricing reforms, Medicaid policy, FDA news and much more.