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  • Regulatory NewsRegulatory News

    Device Firms Discuss Ethylene Oxide Sterilization Ahead of FDA Committee Meeting

    On 6 and 7 November, a US Food and Drug Administration (FDA) medical devices advisory committee will meet to discuss the use of ethylene oxide (EO) to sterilize medical devices and the risks of infection with reprocessed duodenoscopes. The meeting comes as the agency is actively exploring new methods of sterilization, as sterilization facilities have closed down in recent months because of environmental concerns with emissions and as postmarket surveillance studies ...
  • Regulatory NewsRegulatory News

    CDRH Warns of Device Supply Issues Following Suspension of Illinois Sterilization Facility

    Citing concerns of increased cancer risks, the Illinois Environmental Protection Agency (EPA) last month issued a seal order to halt any new sterilization cycles using ethylene oxide at a Sterigenics facility in Willowbrook, IL. “Recent elevated sampling results, along with Sterigenics' refusal to voluntarily suspend operations, have resulted in the issuance of the Seal Order,” the Illinois EPA said . Sterigenics, meanwhile, said in a statement: “The Illinois EPA’s ...
  • Feature ArticlesFeature Articles

    510(k) Submissions: Current Trends and Tips

    This article discusses current trends in the 510(k) submission process, primarily with Class II orthopedic and spinal implants, and will provide tips on maintaining a smooth and successful submission process. This past year has seen the 510(k) submission process evolve and the US Food and Drug Administration (FDA) take a more stringent stance on what submission materials will be accepted. To offset some of the technical impact of a stricter adherence to a more rigorous...
  • Regulatory NewsRegulatory News

    Facilities Sterilizing Devices via 'Novel' Methods Will See New FDA Inspections

    As medical devices are sterilized with novel and sometimes risky new methods and chemical combinations, the US Food and Drug Administration (FDA) announced Wednesday that it will begin inspecting companies' manufacturing facilities before clearing their 510(k) applications. The shift in FDA’s thinking comes as the agency says in Wednesday’s final guidance, issued more than seven years after the draft document was released, that it’s received “an increasing number of 510(...
  • Ability to Clean Devices Emerges as a Safety Issue

    An investigative report by the The Center for Public Integrity (CPI) has found that medical devices that are difficult-or impossible-to clean properly are increasingly behind adverse events. "FDA has done little to solve the problem, despite review findings that suggest [dirty devices are] widespread," writes CPI . FDA does require manufacturers to prove that its cleaning instructions are effective, but CPI ' s report questions if their regulatory approach is ef...