FDA Medical Device Data Systems Rule Still Raising Questions
This article was originally published in The Gray Sheet
Executive SummaryWhile a mid-May deadline has come and gone for makers of "medical device data systems" to register their products with FDA, many are still wondering whether their offerings fall within the agency’s definition of the newly classified device category.
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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.