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FDA Won’t Immediately Dispatch Investigators, ‘Guns Blazing,’ To Enforce UDI Regulation

This article was originally published in The Gray Sheet

Executive Summary

The agency is likely to institute a period of enforcement discretion after impending unique device identification mandates take effect, but it won’t last forever, experts warn.

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FDA Releases Proposed Rule On UDI System, Ushering in ‘Modern Post-Market Surveillance System’

A proposed FDA regulation for a Unique Device Identification System is critical to the future of post-market safety surveillance, the agency says. The UDI system aims to reduce medical errors, and provide an array of other benefits for supply chain management. Makers of high-risk class III products will have one year to place UDI codes on devices. The UDI mandate will extend to moderate-risk class II devices two years later and to some low-risk class I devices two years after that.

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C-Suite Snippets: Growth Of A Cell And Gene Powerhouse

In case you missed it: catch up with snippets from interviews with industry leaders recently published by In Vivo.





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