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."
An Infection Preventionist Considers Why Manufacturers Need to Update IFUs
July 11th 2024Katharine J. Hoffman, MPH, CIC, LSSGB: It’s time to take the devil out of the details in interpreting and successfully following manufacturers' instructions for use; why do manufacturers need to update IFUs?
New ANSI/AAMI Standard Transforms Ethylene Oxide Sterilization in Health Care
July 8th 2024The updated ANSI/AAMI ST24 standard outlines requirements for ethylene oxide sterilizers in health care, addressing advancements, regulatory changes, and new technology to enhance sterilization practices and safety.
The Value of Certification in Infection Prevention and Control: Why Is it important?
May 14th 2024Certification in infection prevention and control is essential for career growth, higher salaries, and improved patient outcomes. Learn why certification matters from Shazia Irum, MSC, MBA, RN, CIC, CPHQ, CBIC Ambassador in Saudi Arabia.