The 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.
