FDA Expects to Release Proposed Rule for UDI Database Before Year End

Three years after Congress mandated that the FDA create a unique device identifier (UDI) regulation and database, the agency is getting close to releasing a proposed rule. The rule is expected to be released in two months, Jay Crowley, the FDA’s senior adviser for patient safety, said. A few weeks ago, Crowley said the agency plans to publish, within the next few months, a request for proposals to begin the development and building of the UDI database, which it hopes to have completed within a year.
Devices & Diagnostics Letter