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More PMAs Would Result From FDA’s Classification Proposed Reg, AdvaMed Warns

This article was originally published in The Gray Sheet

Executive Summary

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.

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