Mar 182011

As the FDA prepares to release its proposed rule for a unique device identifier (UDI) database, devicemakers are off the hook for UDI label scrutiny during premarket review. “It could be that our reviewers want to see some information, but at this point we don’t have any specific plans for UDI to be part of the premarket review,” FDA senior adviser for patient safety Jay Crowley said during an FDAnews webinar Feb. 24. However, a devicemaker would have to submit its data to the UDI database before putting a new product on the market, he added. The UDI would not apply to products that were on the market before it is implemented: Devices & Diagnostics Letter

(Reprint: FDANEWS vol. 8, No. 50)