Business
US Adhesives Reclassification
US Adhesives Reclassification.
About this update from Advanced Medical Solutions Group Plc
[{"type":"text","content":"\n Advanced Medical Solutions Grp PLC\n08 May 2008\n\n\nFor Immediate Release 8 May 2008\n\n\n\n\n\nAdvanced Medical Solutions Group plc\n\n ('AMS' or 'the Company')\n\n\n Reclassification Order\n\n Tissue adhesive for topical skin approximation\n\n\n\nWinsford, UK: Advanced Medical Solutions Group plc (AIM: AMS), the global\nmedical technology company, today announces that the Center for Devices and\nRadiological Health (CDRH) of the Food and Drug Administration (FDA) has\ncompleted its review of a petition submitted by Regulatory and Clinical Research\nInstitute, Inc. (RCRI) of Minneapolis, on behalf of AMS' MedLogic Wound Closure\nDivision, for reclassification of tissue adhesives for topical approximation of\nskin.\n\n\nThe FDA has concluded that these devices and substantially equivalent devices of\nthese generic types should be reclassified from Class III into Class II.\n\n\nThis means that tissue adhesives will now be cleared for commercial distribution\nvia a Premarket Notification 510(k) submission rather than a Premarket Approval\nApplication (PMA).\n\n\nThis order reclassifies tissue adhesives for topical skin approximation, and\nsubstantial equivalent devices of these generic types into Class II under the\ngeneric name 'Tissue Adhesive for Topical Skin Approximation,' effective\nimmediately. This order also identifies the special controls applicable to the\ndevice as the FDA guidance document entitled 'Class II Special Controls Guidance\nDocument : Tissue Adhesive for the Topical Approximation of Skin, Guidance for\nIndustry and FDA Staff.'\n\n\nFDA identifies this generic type of device, the subject of this\nreclassification, as follows:\n\n\nIdentification. A tissue adhesive for the topical approximation of skin is a\ndevice intended for topical closure of surgical incisions, including\nlaparoscopic incisions, and simple traumatic lacerations that have easily\napproximated skin edges. Tissue adhesives for the topical approximation of skin\nmay be used in conjunction with, but not in place of, deep dermal stitches.\n\n\nClassification. Class II (special controls). The special control for this\ndevice is FDA's 'Class II Special Controls Guidance Document : Tissue Adhesive\nfor the Topical Approximation of Skin.'\n\n\nAt a public meeting held on 25 August 2006, following review of the petition\npresented by RCRI and A...