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Regulatory News: User-Fee Talks, 'Critical-To-Quality' Pilot, Genetic Screening Regs

This article was originally published in The Gray Sheet

Executive Summary

The latest FDA-industry user-fee reauthorization talks focused on pre-submissions, IT challenges and more. FDA reported generally positive, early feedback on its "critical-to-quality" inspection pilot program focused on implantable devices that contain batteries. Autosomal recessive carrier screening gene tests are now formally exempt from 510(k) clearance.

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