Home » FDA Expects to Release Proposed Rule for UDI Database Before Year End
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
Devices & Diagnostics Letter
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