What Makes A Device Class III? FDA Proposes New Language To Clarify
This article was originally published in The Gray Sheet
FDA issued a proposed rule that introduces five newly defined categories that describe situations for devices when a class III designation, requiring a PMA and other heightened standards, will always be necessary.
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The industry group argues that the agency’s proposed rule, which, among other things, seeks to clarify the definition of a class III device, would lead to many more devices requiring PMA rather than 510(k) review. The proposal would exceed its regulatory authority set by Congress and could confuse medical device makers, AdvaMed says.