Devicemakers Question Data Requests for FDA’s Prototype UDI Database

Devicemakers testing a unique device identifier (UDI) database say the prototype required information that may be proprietary, unnecessary or not always readily available, according to an FDA report. The test required devicemakers to provide data for up to 47 characteristics, but the final database — which the FDA says would improve its ability to respond to adverse events — should have a more modest set of clearly defined attributes that relate to all products and are globally harmonized where possible, Dennis Black, director of e-business for Becton Dickinson, said.
Devices & Diagnostics Letter