FDA Expects to Publish an RFP Soon to Begin Developing UDI Database

After years of promises, the FDA says it plans to publish, within the next few months, a request for proposals (RFP) to begin the development and building of a unique device identifier (UDI) database. The agency hopes the database will be completed in the next 12 months, Jay Crowley, senior adviser for patient safety at CDRH, said. “The database is not delayed,” he added, noting that technically it was “never on any particular timeline.” The implementation of the database is predicated on the publication of a final UDI rule. But the agency has yet to publish even a proposed rule, although it had hoped to have one out by this past spring.
Devices & Diagnostics Letter