Note: West’s SmartDose® on-body delivery system is not independently cleared or approved by any Regulatory Body for general healthcare professional or patient use, nor is it available for general commercial purchase. Its distribution and use are subject to applicable regulatory requirements for clinical investigation, and for marketing authorization, as used in combination with a specific drug or biological product. Each component of a combination product is subject to the requirements established by the Regulatory Body for that component (drug, biologic or device). The regulatory process can be more complicated for combination products including an evaluation of the product characteristics, delivery system and its functionality, intended users and use environment(s), as well as the potential for undesirable interactions between the drug or biologic and the delivery system. As a result, we note that the SmartDose® on-body delivery system’s compatibility with any particular drug or biologic must be confirmed, and its ability to achieve the desired patient benefits must also be confirmed, on a case-by-case basis in a manner sufficient to meet Regulatory Body requirements. Failure to follow product instructions for use may result in compromised sterility; contamination; leakage (including possible exposure to medication); and/or underdosing. Product misuse could potentially lead to needlestick injury, user and/or patient exposure to pathogens or infection, and/or suboptimal or delayed therapy.
SmartDose® is a registered trademark of West Pharma. Services IL, Ltd., a subsidiary of West Pharmaceutical Services, Inc.
Flurotec® is a registered trademark of Daikyo Seiko, Ltd.
SelfDose™ is a trademark of West Pharmaceutical Services, Inc.
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