Home-Use E-Labeling Pilot Round 2: CDRH Seeks Volunteers
This article was originally published in The Gray Sheet
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.
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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.
The device center will convene a meeting at FDA headquarters in September to discuss all facets of device patient labeling.
Industry representatives, health care providers, patients and caregivers gathered April 29-30 to discuss CDRH labeling activities and the agency’s ideas for the future.