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

This article was originally published in The Silver Sheet

Executive Summary

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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News In Brief

CDRH to publish final version of its national device post-market strategy by March; new UDI guidance coming; and more.

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

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.

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

Details about how FDA will likely enforce its upcoming regulation on Unique Device Identification (UDI) are slowly emerging. Specifically, FDA will probably exercise enforcement discretion to give manufacturers and field investigators time to become accustomed to the new UDI requirements. Discretion action might “extend for the first three months or six months after the regulation goes into effect where FDA will not take aggressive enforcement actions,” former FDA official David Elder said. Ultimately, the agency says it will ensure manufacturer compliance to UDI by pursuing a risk-based approach. Meanwhile, FDA appears to have had a change of heart when it comes to prescribing a U.S.-based expiration date format for product labels.

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