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Home-Use E-Labeling Pilot Round 2: CDRH Seeks Volunteers

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.

FDA is looking for companies to volunteer to submit labeling for home-use to devices to an electronic portal for a pilot project the center plans to launch in the second half of the year.

It’s a step towards a searchable, electronic database of product labeling for devices used in the home. The device center says a database would improve access to product information to...

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