CDRH Accelerates Software Development To Improve Collaboration With Industry

Article preview from "The Gray Sheet" - September 17, 2012

FDA’s device center hopes the effort, which is intended to model a quicker-turnaround “Silicon Valley” approach to system development, will help reduce time-to-market for new devices, and simplify some post-market surveillance efforts.

CDRH Accelerates Software Development To Improve Collaboration With Industry

Article preview from "The Gray Sheet"-  September 17, 2012

CDRH says it is taking rapid steps to upgrade its IT and social networking capabilities to deepen its collaboration with device makers and improve communication with the public.

FDA’s device center hopes the project, which is intended to model a quicker-turnaround “Silicon Valley”-approach to system development, will ultimately help reduce time-to-market for new devices, and simplify some post-market surveillance efforts, says Anjali Kataria, a software executive who is working within CDRH as part of its entrepreneur-in-residence program.

One outcome of the ongoing IT overhaul will surface this week, when the device center plans to release an online “help desk” to assist companies in implementing a mandatory system of unique device identifiers. FDA issued a draft UDI rule in July as a step toward establishing a universal system of barcodes and other identifiers linked to individual devices, with the first requirements scheduled to take effect in 2014.

 

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