Industry Groups Criticize Proposed Home-Use Device Database

An FDA proposed rule establishing a centralized public database of labels and package inserts for some home-use medical devices might cause confusion if those versions differ from versions on manufacturers’ websites, industry groups have said in public comments.

The rule would require manufacturers of Class II and Class III devices to submit electronic copies of the labels and package inserts for those products to the database. According to the agency, this would help reduce adverse events caused by lost instructions.

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