In addition, we’ve previously announced we’re holding a public advisory committee meeting on November 6 and 7, 2019, dedicated to discussing how best to encourage innovation in medical device sterilization. We also continue to collaborate with the U.S. EPA, the entity responsible for reviewing and enforcing Clean Air Act regulations for sterilization facilities that emit ethylene oxide to ensure that facilities protect the public from significant risks, providing the U.S. EPA with updates on FDA activities in this area. And we’ll continue to update stakeholders and the public as new information becomes available.

We want to be clear that we understand that there are very real consequences that medical device shortages have on patients, and we’re committed to doing everything in our authority to help mitigate the adverse patient impact these sterilization facility closures are expected to have. We’re also calling on all stakeholders—manufacturers, contract sterilizers, government agencies and other public health advocates—to join us and do your part to avert new device shortages and ensure patients have access to important and life-saving medical devices.


The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Back to HCB News

U.S. Healthcare Homepage