• Feature ArticlesFeature Articles

    August’s Regulatory Focus: Alternative regulatory pathways

    Feature articles during August focused on alternative global regulatory pathways and their use in providing faster, easier access to new treatments for unmet medical needs. Articles examined emergency use authorizations for in vitro diagnostics (IVDs) in the US, as well as regulatory pathways for laboratory developed tests (LDTs), innovative medicinal products in Switzerland, software as a medical device (SaMD) in the US and Europe, and cell and gene therapy products in Ja...
  • 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

    Georgia Seeks to Shutter BD Device Sterilization Facility

    Georgia Attorney General Chris Carr earlier this week filed a complaint in court to temporarily halt Becton, Dickinson and Company (BD) from operating its Covington, Georgia medical device sterilization facility. Carr alleges that in September, BD released 54.5 pounds of ethylene oxide, which is often used to sterilize devices, into the atmosphere because of “a lack of diligence and prolonged operator error rather than an equipment malfunction.” He also said that the...