FDA Won’t Immediately Dispatch Investigators, ‘Guns Blazing,’ To Enforce UDI Regulation
This article was originally published in The Gray Sheet
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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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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