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AAMI Document Will Help Explain FDA Requirements For Builders Of Medical Device Data Systems

Coming soon: A plain-language document for medical device data systems developers such as hospitals and small IT vendors that have little experience with FDA regulation.

An AAMI document due for publication in mid-April will offer plain-language help for hospitals and IT vendors affected by FDA's 2011 regulation on medical device data systems.

Under FDA's Feb. 14, 2011, medical device data systems (MDDS) rule, those designing software systems that passively store data collected from medical devices have until April 18 of this year to put in place a quality system and procedures for adverse event reporting; they were to have registered as medical device makers by last May

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