Regulatory Affairs
Learn more about our Regulatory Affairs work.
FDA Warns of “Tipping Point” with Medical Device Supplies and EtO Facility Closures
WASHINGTON, DC. – A top FDA official warned that additional closures of ethylene oxide (EtO) sterilization plants could lead to shortages of critical medical devices across the country.
AdvaMed®: Neonatal Products Provided to 80 Percent of U.S. Hospitals Threatened by Potential Medline Shutdown
Medela LLC, headquartered in McHenry, Illinois, today wrote to Illinois state house speaker Michael Madigan saying they “respectfully oppose HB 3888 and HB 3885 because their restriction to EO use would…
AdvaMed® Comments on FDA Statement on Potential Device Shortages
WASHINGTON, D.C. – AdvaMed® released a statement on FDA’s announcement today that the agency is concerned about medical device shortages in light of two recent closures of ethylene oxide sterilization…
Nation’s Premier Surgeons Stress Importance of Ethylene Oxide for Medical Device Sterilization
WASHINGTON, D.C. – This week, six leading medical groups sent a letter to FDA urging caution as regulators consider limiting the use of ethylene oxide (EtO) for medical device sterilization. The surgeons…
Quality Function Deployment (QFD) for Design Controls
This white paper covers the history and evolution of quality systems and their application to medical devices.
Successful Practices for Battery Powered Medical Devices
This document provides successful practices for the development, manufacture, and use of batteries in medical device applications