Electronic Labeling Submissions Proposed For Home-Use Devices
US FDA is proposing a rule that would require manufacturers to electronically submit labeling and package inserts for class II and III devices that are intended for use outside health-care facilities. The agency is also planning a public database of the labeling.
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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.
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.
FDA’s device center issued a request to participate for a pilot asking companies to electronically submit labeling for home-use devices to help develop a label database. This is the agency’s second go at such a pilot but the submissions process appears to be simplified this time around.