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Biotech / Medical : PSDV - pSivida Limited -- Ignore unavailable to you. Want to Upgrade?

To: John McCarthy who wrote (185)	9/27/2009 3:17:29 PM
From: John McCarthy	Read Replies (1) \| Respond to of 421

P#9 - pSivida Ltd. Reports Operating Results (10-K) gurufocus.com gurufocus.com SEVERE EDIT - SELECTION - REARRANGEMENT In the event that we seek approval of BrachySil as a device in the United States, we would need to satisfy different regulatory requirements. Products that are classified as devices also require some form of FDA clearance or approval prior to marketing. Devices are classified as Class I, II or III, depending upon the information available to assure their safety and effectiveness. In general, Class I and Class II devices are devices whose safety and effectiveness can reasonably be assured through general or specific controls, respectively. Class III devices are life sustaining, life supporting, are of substantial importance in preventing impairment to health or pose an unreasonable risk of adverse effect. They include implantable devices or new devices which have been found not to be substantially equivalent to legally marketed devices. The steps required for approval of a Class III device include: • pre-clinical laboratory tests and in vitro and in vivo pre-clinical studies; submission to the FDA and approval of an Investigational Device Exemption (IDE) application to allow initiation of clinical testing; • human clinical studies to prove safety and effectiveness of the device; • submission to the FDA of a Pre-Marketing Approval application (PMA); and • approval by the FDA of the PMA. Typically, clinical testing of devices involves initial testing to evaluate safety and feasibility and expanded trials to collect sufficient data to prove safety and effectiveness. In addition, the procedures and the facilities used to manufacture the device are subject to review and approval by the FDA.