NeoMed Inc (Woodstock, GA) announced 510(k) clearance from the FDA (Rockville, MD) of its line of sterile oral/enteral syringes. The new sterile oral/enteral syringes complement NeoMed’s lines of clear, amber and bulk pharmacy pack oral dispensers. NeoMed also received a certification for the successful registration of its quality management system for sterile feeding tubes, extension sets, syringes, umbilical vessel catheters, and urinary drainage catheters to both the ISO 13485:2003 standard, and the requirements of the Canadian Medical Devices Conformity Assessment System (CMDCAS). The Canadian Medical Device Regulations require compliance with ISO 13485:2003 as well as regulations specific to Canada.
