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FDA proposes pilot program for alternative medical device sterilization methods

June 8, 2022 By Chris Newmarker

FDA logoThe FDA is considering ways to make it easier for medical device manufacturers to switch sterilization methods.

The proposed master file pilot program, announced yesterday, would be for premarket approval holders whose approved devices are sterilized using radiation, including gamma radiation.

Said the FDA: “If implemented, this program would help medical device manufacturers advance alternative ways to sterilize their approved medical devices, including changing radiation sources, in a least burdensome regulatory approach.”

The agency said the pilot program would not be for 510(k)-cleared devices because such devices already do not require a new 510(k) submission for a change from gamma to another radiation source.

FDA officials think the program could help alleviate global supply chain constraints and support sterilization supply chain resiliency.

Overall, the FDA has been seeking to promote alternative medical device sterilization methods as another important sterilization option — ethylene oxide (EtO) — draws increased scrutiny from the EPA.

 

About The Author

Chris Newmarker

Chris Newmarker is the executive editor of WTWH Media life science's news websites and publications including MassDevice, Medical Design & Outsourcing and more. A professional journalist of 18 years, he is a veteran of UBM (now Informa) and The Associated Press whose career has taken him from Ohio to Virginia, New Jersey and, most recently, Minnesota. He’s covered a wide variety of subjects, but his focus over the past decade has been business and technology. He holds bachelor’s degrees in journalism and political science from Ohio State University. Connect with him on LinkedIn or email at cnewmarker@wtwhmedia.com.

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