FDA Suspends Activities at Invacare

Whether medical device professionals/engineers/manufacturers acknowledge it on a daily basis, the FDA has the power to shut a company down if they feel that it poses a threat to the general safety of Americans. Note this latest example: Invacare article.

Many of us have heard the complaints of regulatory oversight, but there are serious consequences if they are not followed. Human lives are affected in either situation – companies can harm patients and users of the devices, or harm their own employees by eliciting fines, criminal punishment, or a closure. This serves as a harsh reminder of the landscape of manufacturing medical devices; tread lightly.

-RTK


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