Alternative Sterilization Methods – Tips For Navigating FDA's 510(k) Approval Process
Traditional sterilization methods for medical and biotech devices have increasingly repressed opportunities for design advancements, and have halted the use of material components that could mean the difference between success and failure. A non-traditional sterilization method, one that uses room-temperature vaporized peracetic acid (VPA), is able to meet the modern demands of innovation, and is now approved by the new FDA 510(k) amendment. This application note describes how OsteroSymbionics was able to use the new amendment to gain 510(k) approval for their cranial implant sterilization method utilizing the innovative room-temperature sterilization. Download the full paper for more on the 510(k) approval process, and whether or not it is worth seeking re-approval for a new sterilization solution.
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