Most Device Makers Not Ready For UDI

by Maureen Perroni, on August 18, 2016

Screen_Shot_2016-08-17_at_3.44.21_PM.pngSeptember 24 marks the next deadline for the FDA's UDI requirements.

Conducted by Loftware and USDM Life Sciences, a recent UDI readiness survey report found that only 15 percent of Class II medical device makers are in compliance with the next phase of regulation, which will apply to about 43 percent of the market. Devices such as condoms, wheelchairs and pregnancy tests will require UDI barcodes, according to Modern Healthcare.

The survey also found that more than 70 percent of all manufacturers don't have one standardized labeling software system. This may be part of the reason why so many are struggling to get the information they need on their product labels. An Enterprise Labeling Solution can use a single source of truth to help them meet their specific needs.

Download our survey report on UDI readiness today.

Read the Survey Report

Topics:Medical DevicesRegulatory