What Makes A Device Class III? FDA Proposes New Language To Clarify
This article was originally published in The Gray Sheet
Executive Summary
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.
You may also be interested in...
US FDA Shelves Proposal To Mandate Home-Use Device E-Labeling
A controversial 2016 proposed rule that would have required manufacturers of many class II and class III home-use devices to electronically submit device labeling information to US FDA will not be finalized, the agency affirmed in the Oct. 17 HHS Unified Agenda document. The agency also signaled plans to imminently finalize a broad device classification rule, and other updates.
Editors' Picks: Six Themes From 2014
Industry closely scrutinized FDA's premarket review performance as the agency took steps to streamline reviews and remake the U.S. postmarket surveillance system. Meanwhile: device mega-mergers accelerated; one of the most hotly anticipated medtech innovations faltered; and national elections swept in Republican control of Congress. Here is a look back at coverage and analysis from "The Gray Sheet" on six key themes for the medical device and diagnostics industry in 2014.
More PMAs Would Result From FDA’s Classification Proposed Reg, AdvaMed Warns
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.