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The system’s built-in lock-out mechanism prevents the device from being used for a period of time after a pre-defined number of spray actuations. Read More
The FDA lacks a good mechanism for dealing with the hundreds of device accessories currently on the market which may be inappropriately classified, and a new House bill proposes to streamline the process. Read More
The FDA cited four devicemakers for a variety of problems observed during inspections, including a lack of written quality procedures, shipping products prior to approval, inadequate documentation, and failure to report a software change. Read More