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Canadian company TSO3 Inc., an innovator in sterilization technology for medical devices in healthcare settings, today announced that the company is having productive discussions with U.S. regulators; the company is actively engaged in the changing U.S. regulatory process intended to lead to the refiling for 510(k) clearance on its new-generation sterilizer.
"Based on recent disclosure from the U.S. Food and Drug Administration (FDA), we can see a changing emphasis on what is expected for devices to clear the 510(k) process," says Charles O. Hancock, RAC, regulatory consultant for TSO3. "The agency wants to make the process more predictable. This means more discussions and guidance upfront before filings, which is intended to lead to a more predictable and timely review."
R.M. Rumble, TSO3's president and CEO, notes, "We understand the nature of the regulators' process and are confident we can respond to their need for scientifically valid explanations and justifications in a timely manner. This new process we are currently engaged in with the U.S. regulators involves more discussions before we are ready to file. We see this positively as it will make the outcome of our filing more predictable. We are very confident in our ability to respond with a compliant submission and will disclose when we file our new application."