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FDA Home-Use e-Labeling Proposal Gets Serious Pushback From Medtech Firms

Executive Summary

The US agency's proposed rule mapping out a system for requiring manufacturers of many class II and class III home-use devices to submit device labeling and packaging to FDA electronically is unnecessary and could create confusion, several industry groups argued in recent comments. In addition, several groups pointed to specific exemptions that should be made from the mandate, including mobile devices and other medtech products with embedded software.

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