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FDA Proposes to Create Database of Class II and III Home-Use Device Labels

October 18, 2016

To help reduce adverse events caused by lost instructions, the FDA is proposing to create a database of device labels and package inserts for certain home-use devices.

Because manufacturers often don’t keep instructions on their websites for products they are not actively marketing, the FDA is stepping in.

The database would be run by the FDA or a partner with links to other FDA information concerning home-use devices, such as premarket submission information, adverse event reports, alerts, notices, and recalls, as well as FDA information concerning the manufacturer. — Jeff Kinney

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