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3 Key FDA Topics for Medtechs in 2022, MedTech Dive

February 01, 2022

Despite the decrease in warning letters sent to medical device manufacturers by the Food and Drug Administration (FDA) from 2015 through 2019, partner Dennis Gucciardo tells MedTech Dive that the industry should be prepared to see a continuation of 2021’s increased compliance enforcement in 2022. Dennis also believes the FDA is poised to ramp up for-cause and routine inspections, noting that in Q4 2021 these “came back with a roar.”

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