But as applied to devices, it just means that the device could fail, and may not imply that it is life-threatening.Â In non-life-threatening cases, the terms "advisory notice" or "safety alert" would be more appropriate, the report states. AdvaMed is on record as agreeing, and FDA says it will consider the proposal. It seems like a good idea provided that life-threatening problems are still reported with urgent language. Also of note is that the Star Tribune article did an excellent job of differentiating devices from drugs, which eludes much mainstream media coverage.
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