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

 
• By Shawn M. Schmitt

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.

Big yellow warning road sign Danger ahead.

Industry should brace for a wave of medical device recalls and US regulatory enforcement actions as a result of the Food and Drug Administration’s relaxed approach to compliance and wide distribution of emergency use authorizations (EUAs) during the coronavirus pandemic, experts warn.

“Some of the emergency authorizations and relaxed regs are needed right now to get through the pandemic, but we do also feel that it could lead to product issues or...

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