FDA warns Kimberly-Clark
Device Regulation Alert: Safety, Compliance and Reimbursement News, September 22, 2008
Kimberly-Clark significantly changed 12 models of previously approved sterilization wraps and needed marketing clearance before selling the devices, according to an FDA warning letter.
Kimberly-Clark initially told the FDA it did not make significant changes to the wraps and marketed them under the previous approval. However, the FDA disagreed and said the devices are adulterated and misbranded because the company did not adequately justify why it did not submit 510(k)s or PMAs for the devices.
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