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BioWorld - Saturday, July 18, 2026
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Home » FDA warning letters hint that med-tech compliance programs drifted during COVID
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FDA warning letters hint that med-tech compliance programs drifted during COVID

June 7, 2023
By Mark McCarty
The U.S.FDA posted two warning letters to medical device manufacturers June 6, one each to Irhythm Technologies Inc., and Steiner Biotechnology LLC, and both warnings include citations for marketing for claims that are not in the FDA-reviewed product labels.
Medical technology Regulatory U.S. FDA

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