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Expect Surge In Recalls, Enforcement Actions When FDA’s Soft Touch Ends, Inspections Resume, Experts Warn

Executive Summary

Two industry experts say device makers that became complacent during the coronavirus public health emergency will be in for a rude awakening when the US FDA retightens its regulatory grip after the worst of the pandemic fades. Aside from a probable uptick in enforcement actions, there will likely be a wave of product recalls in part because the agency passed out emergency use authorizations like Tic Tacs and paused routine surveillance inspections in March.


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