FDA Considers Pilot Program for Radiation Sterilization of Medical Devices
The FDA is considering a master file pilot program for premarket approval holders whose approved devices are sterilized using radiation.
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SHYCOCAN Device Disables COVID-19
Shreis Scalene Therapeutics will fast-track the manufacture and distribution of the CE-marked SHYCOCAN under U.S. FDA ”Enforcement Policy for Sterilizers, Disinfectant Devices, and Air Purifiers During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency."
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First Claim for Validated Sterilization of Duodenoscope Initiated in Canada
TSO3 Inc, a maker of sterilization technology for medical devices, has received a label claim for the Sterizone VP4 sterilizer in Canada that validates the ability to sterilize a specific duodenoscope, reportedly cleansing it of transmittable germs.
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FDA Considers Pilot Program for Radiation Sterilization of Medical Devices
The FDA is considering a master file pilot program for premarket approval holders whose approved devices are sterilized using radiation.
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