FDA Stakeholder Update - September 5, 2019

Dear Colleague, FDA's Stakeholder Engagement Staff works to provide you with up-to-date information that helps to further our commitment in advancing public health and well-being.

FDA Announcements FDA sends warning to company for selling unapproved umbilical cord blood and umbilical cord products that may put patients at risk; continues to warn patients of the risk of unapproved stem cell therapy FDA has warned Stemell, Inc., of San Juan Capistrano, California, and its president and Chief Executive Officer, Peyman Taeidi, Ph.D., for manufacturing and distributing unapproved products derived from umbilical cord blood and umbilical cord and for significant deviations from current good tissue practice (CGTP) and current good manufacturing practice (CGMP) requirements, including deficient donor eligibility practices and environmental monitoring, creating potential significant safety concerns that put patients at risk. Stemell’s unapproved products derived from umbilical cord blood and umbilical cord are StemL UCB-Plus and StemL UCT-Plus. [09/03/2019] FDA plans to hold an advisory committee meeting Nov. 6-7 to discuss ethylene oxide (EtO) sterilization of medical devices and its role in maintaining public health as well as the risks of infection with reprocessed duodenoscopes. The committee will discuss the topic of industrial ethylene oxide (EtO) sterilization of medical devices and its role in maintaining public health as well as the risks of infection with reprocessed duodenoscopes. Subject matter of the panel meeting will include potential methods and expert assessment of how to reduce EtO emissions to the environment from medical device sterilization processes without compromising assurance of sterility or effective processing of medical devices.  The panel will also discuss recommendations to reduce the risk of infection from reprocessed duodenoscopes. [09/04/2019]

FDA In Brief FDA provides transparency and clarity on the Humanitarian Device Exemption pathway, helping bring more life-saving medical devices to patients in need The FDA issued a final guidance, Humanitarian Device Exemption (HDE) Program, to provide updated information about the HDE application process and other considerations specific to the HDE Program. An HDE application is the premarket submission for a Humanitarian Use Device (or HUD), which is a medical device intended to benefit patients in the treatment or diagnosis of a disease or condition that affects, or is manifested in, not more than 8,000 individuals in the United States per year. A device approved under an HDE application is exempt from the requirement to demonstrate a reasonable assurance of effectiveness. To be eligible for an HDE, the FDA must determine, among other things, that the device would not be available to a person with the disease or condition in question without the HDE approval and that there is no comparable device, other than another device approved under an HDE or Investigational Device Exemption (IDE), available to treat or diagnose the disease or condition. [09/05/2019] Public Meetings/ Workshops September 10, 2019: Patient Engagement Advisory Committee Meeting Announcement Time: 08:00 AM ET-05:30 PM ET Agenda: The committee will discuss and make recommendations on the topic “Cybersecurity in Medical Devices: Communication That Empowers Patients.”  Medical devices are increasingly connected to the internet, hospital networks, and other medical devices to provide features that improve healthcare and increase the ability of healthcare providers to treat patients. November 6-7, 2019: General Hospital and Personal Use Devices Panel of the Medical Devices Advisory Committee Meeting Time: 08:00 AM ET-06:00 PM ET Agenda: The committee will discuss the topic of industrial ethylene oxide (EtO) sterilization of medical devices and its role in maintaining public health as well as the risks of infection with reprocessed duodenoscopes.