Andersen Sterilizers Awarded First 510(k) Master File for EtO Sterility Change
Now, companies wanting to switch EtO sterilization methods can reference the company’s master file rather than submitting a new 510(k).
In a major win for companies hoping to minimize the amount of ethylene oxide (EtO) needed to sterilize medical devices without the risk of 510(k) resubmission, Andersen Sterilizers and its contract sterilization specialist sister company, Andersen Scientific, announced it’s been awarded the very first master file in the FDA’s 510(k) EtO Sterility Change Master File Program.
The pilot program, which was born out of EPA and FDA’s mission to reduce EtO emissions, aims to remove regulatory hurdles when changing sterilization methods. Previously when changing methods, there would be a risk that companies would have to re-submit a 510(k) for a device. Now, 510(k) class I or class II device holders labeled as sterile can reference the Andersen Sterilizers master file rather than submitting a new 510(k) for the sterilization change.
“In 2019 we were very proud to be selected as a winner of FDA’s Innovation Challenge 2, which was an initiative by FDA to identify ways of using [EtO] more efficiently,” A.E. May, president and CEO of Andersen Scientific, told MD+DI. “For the winners of this initiative, the FDA agreed to help remove regulatory hurdles to the adoption of gas-efficient technologies. In our case the request was simple. When a medical device manufacturer changes sterilization methods, there is the risk that they will be asked by FDA to re-submit a 510(k) for their device. With the FDA’s Medical Device Master File program, the transition to an Andersen sterilization system just became a lot easier.”
Andersen Sterilizers sterilization systems, including the EOGas 4 or EOGas 3 in-house systems as well as Andersen Scientific's contract sterilization services, use proprietary flexible chambers in tabletop and refrigerator-sized versions, which require 85-90% less EtO gas compared to current systems. The company specializes in small to medium lot sterilization, custom cycles, and fast turnaround for the manufacturing, research, medical, and veterinary markets.